Data / Medical devices / Germany / Richard Wolf GMBH
Richard Wolf GMBH: FDA-registered device maker in KNITTLINGEN Baden-Wurttemberg, Germany, 104 510(k) clearances
Richard Wolf GMBH is registered with the FDA (registration 9611102) in KNITTLINGEN Baden-Wurttemberg, Germany. It lists 168 device types. The FDA files 104 510(k) clearances under its listings, the newest dated June 3, 2024. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611102
- FEI number
- 3002808001
- Address
- Pforzheimer STR. 32, KNITTLINGEN Baden-Wurttemberg, Germany, 75438
- Owner or operator
- RICHARD WOLF GMBH (8010049)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 31, 1978
- Registered through
- 2027
- Brand names listed
- 68601, 68602, AND 68603, 86xxxxx 8517xx, D Camera Controller, Eragon Stitch, HF Surgery Generator 400KHz, Headlamp 45260, LOGIC 4K Camera Controller 5525301 and LOGIC 4K Camera Head 85525942, RIWO D-URS and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 104.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2024 | K231291 | Perforated Baskets | KCT | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| March 22, 2023 | K230194 | HF Surgery Generator 400KHZ | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| June 14, 2022 | K212808 | Logic Hd camera head green, System green | FET | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| October 1, 2021 | K211332 | D Camera Controller | FET | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| May 14, 2021 | K203226 | TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM | GCM | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| January 15, 2021 | K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 | FGB | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| June 23, 2020 | K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 | FET | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| May 3, 2019 | K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF | FGB | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| June 28, 2018 | K180583 | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD | FET | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| April 5, 2017 | K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| January 11, 2017 | K161204 | ENDOCAM Flex HD Camera System 5521 | FET | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| January 12, 2016 | K151282 | core nova Complete Operating Room Endoscopy | ODA | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 3, 2013 | K130423 | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 | FET | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 20, 2012 | K121724 | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 | FCW | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 3, 2012 | K120898 | KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA | OTJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| June 29, 2009 | K080365 | MORCE POWER PLUS AND VARIOCARVE MORCELLATOR | HET | Substantially Equivalent | NOUVAG AG | accessdata.fda.gov |
| June 27, 2008 | K080617 | POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES | HRX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 14, 2008 | K080977 | 3 CCD ENDOCAM 5550 | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 22, 2007 | K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES | FJL | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| November 23, 2005 | K052745 | ASSISTO ARM SYSTEMS | GWG | Substantially Equivalent | Geomed Medizin-Technik GmbH & Co. | accessdata.fda.gov |
| October 28, 2005 | K051276 | HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM | OCZ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| October 5, 2005 | K051176 | FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 | FAJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 18, 2005 | K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES | FJL | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 19, 2004 | K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 | FJL | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| July 29, 2004 | K031858 | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES | GWG | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| July 9, 2004 | K041321 | VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM | HET | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 11, 2004 | K033177 | POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX | HET | Substantially Equivalent | Gunter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| January 15, 2004 | K033927 | ARTHOSCOPY PUMP A115 | HRX | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| December 23, 2003 | K033113 | UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 | HIH | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 10, 2003 | K022449 | HYSTEREOSCOPY PUMP HM4 | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| January 17, 2003 | K023813 | BIPOLAR FORCEPS | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 18, 2002 | K020255 | RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 | ODA | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 17, 2001 | K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX | FFK | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 10, 2001 | K011496 | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 | FBO | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 9, 2001 | K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) | FFK | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 10, 2001 | K002000 | MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 4, 2001 | K003417 | MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET | HET | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 2, 2001 | K000180 | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP | HIF | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| January 8, 2001 | K003164 | TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM | HET | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| June 5, 2000 | K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | FGA | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 26, 2000 | K001253 | SURGITRON IEC II | GEI | Substantially Equivalent | Ellman Intl., Inc. | accessdata.fda.gov |
| May 26, 2000 | K000673 | HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 | HIH | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 12, 2000 | K000905 | URETHROTOME 8667.XXX AND 8670.XXX | EZO | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 30, 2000 | K000046 | KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) | HRX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| December 10, 1999 | K993103 | ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES | GCM | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| November 23, 1999 | K991906 | LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT | HIF | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| October 25, 1999 | K990397 | FLEXIBLE FIBERSCOPES & ACCESSORIES | HRX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 24, 1999 | K992526 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE | EOB | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 12, 1999 | K991718 | OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 12, 1999 | K984304 | RIWO DRIVE GENERATOR | HRX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 16, 1999 | K990147 | BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 | HIN | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 26, 1999 | K990050 | URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 | FGB | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 5, 1999 | K984607 | PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX | FBP | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| December 4, 1998 | K983236 | BIPOLAR HF CABLE | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| November 5, 1998 | K980129 | INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS) | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 31, 1998 | K982677 | UNI/MONOPOLAR HF CABLE | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 27, 1998 | K973943 | INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| July 20, 1998 | K980302 | WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES | HIH | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| July 7, 1998 | K981321 | BIPOLAR FORCEPS SET (MODULAR) | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 21, 1998 | K980401 | FLEXIBLE FIBERSCOPES AND ACCESSORIES | FAJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 10, 1998 | K970961 | VAPORIZATION ELECTRODES | KNF | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| December 17, 1997 | K973648 | MINI FORCEPS WITH HF, 3.5MM; MICRO FORCEPS WITH HF, 2MM | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| December 12, 1997 | K973737 | MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M | HET | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| November 25, 1997 | K964276 | ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR | HEW | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| November 24, 1997 | K973359 | PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| November 13, 1997 | K973341 | HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| November 6, 1997 | K972927 | ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| October 29, 1997 | K970162 | NEUROLOGICAL ENDOSCOPE | GWG | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 19, 1997 | K972008 | ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES | GEI | Substantially Equivalent | European Surgical, Inc. | accessdata.fda.gov |
| September 15, 1997 | K971315 | AUXILIARY INSTRUMENTS FOR URS | FCL | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 8, 1997 | K972519 | GRASPING FORCEPS, RIGHT AND LEFT CURVED | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 27, 1997 | K971166 | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE | EWY | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 14, 1997 | K971540 | AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD | GEI | Substantially Equivalent | American Biosurgical, Inc. | accessdata.fda.gov |
| May 21, 1997 | K964329 | UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 3, 1997 | K963855 | 12 URETEROSCOPES/URETERO-RENOSCOPES | FGB | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 4, 1997 | K970105 | RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS | HET | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| November 26, 1996 | K963757 | IRRIGATION/SUCTION HANDLE AND SHEATH | EOB | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| October 2, 1996 | K953983 | EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE | FAS | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 29, 1995 | K953868 | GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH | HRX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 26, 1995 | K945914 | BIPOLAR GENERATOR MODEL 2352 | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| July 25, 1995 | K952696 | XENON LIGHT SOURCE MODEL 5121 | GCT | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 23, 1995 | K940179 | ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011 | HRX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 12, 1995 | K951715 | ENDO IRRIGATOR 2211, INCLUDING TUBING | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| January 18, 1995 | K941222 | OPEN LAPAROSCOPY TROCAR CONE SYSTEM | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| December 13, 1994 | K944607 | MODEL 5135 AUTO LP/FLASH | GCT | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| September 7, 1994 | K935163 | CONTINUOUS IRRIGATION CYSTOURETHROSCOPE | FBO | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 26, 1994 | K935270 | MODULAR FORCEP AND SCISSOR SYSTEM | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 24, 1994 | K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | HET | Substantially Equivalent | Endo Technic Corp. | accessdata.fda.gov |
| August 11, 1994 | K940234 | CARPAL TUNNEL SYSTEM | HRX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| June 6, 1994 | K941136 | KNOT SLIDE 8383.55 AND 8383.551 | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 25, 1994 | K942201 | LAPAROSCOPY DILATION SYSTEM | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| May 2, 1994 | K940844 | MYOMA DRILL 5MM-8383.611 | HET | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 20, 1994 | K940900 | APPENDIX EXTRACTOR 8385.50 | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 15, 1994 | K931755 | RIWOLITH 2280 PROBES | FFK | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| March 7, 1994 | K934883 | 3D VIDEO SYSTEM | FWG | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| February 1, 1994 | K932441 | SERIES 8920 TROCAR SYSTEM | GCJ | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| December 7, 1992 | K920235 | ULTRASOUND GENERATOR MODLE 2270 | FEO | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| April 16, 1991 | K910716 | MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE | FCX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
| August 25, 1988 | K880314 | HYSTEROSCOPE AUTONOM 4992 | HIH | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 9, 2025 | 96692 | Class II | Ongoing | PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager). | The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs. | accessdata.fda.gov |
| March 24, 2023 | 91953 | Class II | Ongoing | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope. | accessdata.fda.gov |
| June 25, 2021 | 88249 | Class II | Terminated | CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 | Product labeled as Cutting Electrode may contain BIVAP electrode. | accessdata.fda.gov |
| June 5, 2020 | 85863 | Class II | Terminated | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the low | Tube material of a smaller diameter was used. | accessdata.fda.gov |
| October 17, 2018 | 81169 | Class II | Ongoing | Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and | There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen. | accessdata.fda.gov |
| March 11, 2018 | 79886 | Class II | Terminated | RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery. | Tube ends may be mixed up. | accessdata.fda.gov |
| July 24, 2017 | 80583 | Class II | Ongoing | Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches | Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury. | accessdata.fda.gov |
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Updated May 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.