Data / Medical devices / Canada / Karl Storz Endoscopy Canada Ltd.
Karl Storz Endoscopy Canada Ltd.: FDA-registered device maker in Mississauga Ontario, Canada, 87 510(k) clearances and 2 PMA approvals
Karl Storz Endoscopy Canada Ltd. is registered with the FDA (registration 3012322232) in Mississauga Ontario, Canada. It lists 62 device types. The FDA files 87 510(k) clearances and 2 PMA approvals under its listings, the newest dated March 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012322232
- Address
- 7171 Millcreek Drive, Mississauga Ontario, Canada, L5N 3R3
- Owner or operator
- KARL STORZ Endoscopy Canada Ltd. (10084187)
- Roles
- Exporter to the US
- First device listed
- January 24, 2022
- Registered through
- 2026
- Brand names listed
- KARL STORZ SE & CO. KG
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 17, 2023 | K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | FJL | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| December 20, 2022 | K221004 | HOPKINS Telescopes | GCJ | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| November 10, 2022 | K222504 | H1 | GCJ | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| June 23, 2022 | K213194 | HD Mediastinoscope | EWY | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| May 13, 2022 | K221174 | Telepack + | FET | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| January 20, 2022 | K212458 | Flexible Video-Uretero-Renoscope SSU System | FGB | Substantially Equivalent | Karl Storz Endoscopy America | accessdata.fda.gov |
| February 25, 2021 | K201945 | KARL STORZ UDEL Sterilization Trays | KCT | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| August 17, 2020 | K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head | OWN | Substantially Equivalent | Karl Storz-Endoscopy-America, Inc. | accessdata.fda.gov |
| August 11, 2020 | K200740 | HD Video Rhino Laryngoscope | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 27, 2020 | K192090 | CMOS Video Rhino-Laryngoscope SSU | EOB | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| October 31, 2018 | K180735 | Endomat Select | HIG | Substantially Equivalent | Karl Storz SE & CO. KG | accessdata.fda.gov |
| August 2, 2017 | K171717 | AUTOCON III 400 | GEI | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| March 16, 2017 | K162880 | TIPCAM 1S 3D System | GWG | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| March 2, 2017 | K162410 | TIPCAM 1S 3D System | EOB | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| March 2, 2017 | K161554 | ENDOFLATOR 40, ENDOFLATOR 50 | HIF | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 17, 2016 | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | GWG | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 31, 2016 | K152583 | KARL STORZ Endoscopic ICG Imaging System | OWN | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 20, 2013 | K131953 | IMAGE1 SPIES | FET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 27, 2012 | K122096 | KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM | HAW | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 28, 2012 | K103467 | CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 29, 2011 | K103308 | AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE | LLZ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 18, 2009 | K090818 | KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS | KCT | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 18, 2008 | K082925 | XENON-100 SCB LIGHT SOURCE, MODEL 20132620 | GCT | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 10, 2008 | K082046 | KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO | FBO | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 21, 2006 | K061541 | KSEA BIPOLAR ELECTROTOME | FAS | Substantially Equivalent | Ksea | accessdata.fda.gov |
| August 3, 2001 | K010345 | KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS | HRX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 28, 2001 | K011359 | MODIFICATION TO KSEA ENDOTIP SYSTEM | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| April 27, 2001 | K003325 | KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM | FET | Substantially Equivalent | Karl Storz Imaging, Inc. | accessdata.fda.gov |
| July 19, 2000 | K001630 | KSEA BIPOLAR COAGULATING ELECTRODES | GWG | Substantially Equivalent | Karl Storz Endoscopy | accessdata.fda.gov |
| September 9, 1999 | K992027 | KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR | HIH | Substantially Equivalent | Karl Storz Endoscopy | accessdata.fda.gov |
| June 3, 1999 | K991069 | KSEA NEURO-FIBERSCOPE | GWG | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 18, 1998 | K983363 | DCI ENDOSCOPE | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 6, 1998 | K982837 | KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS | GWG | Substantially Equivalent | Karl Storz Endoscopy | accessdata.fda.gov |
| October 5, 1998 | K982905 | MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE | FGB | Substantially Equivalent | Karl Storz Endoscopy | accessdata.fda.gov |
| August 27, 1997 | K972497 | KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES | GEI | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 14, 1996 | K963524 | KSEA LARGE JOINT ARTHROSCOPY SET | HRX | Substantially Equivalent | Karl Storz Endoscopy | accessdata.fda.gov |
| November 13, 1996 | K961605 | KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE | HIH | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| October 3, 1996 | K961091 | KARL STORZ MODEL 203020 20 EQUIMAT | HIG | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 27, 1996 | K962396 | KSEA BIPOLAR GOAGULATING FORCEPS | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 14, 1996 | K962030 | KARL STORZ REMORGIDA FORCEPS | GEI | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 31, 1996 | K961713 | INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY | HRX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| April 11, 1996 | K951343 | KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES | HET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 17, 1996 | K954797 | KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY | EOQ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 4, 1995 | K955272 | TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY | HRX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 4, 1995 | K954981 | KARL STORZ HEMPFLING DILATION SET | HRX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 22, 1995 | K954050 | RESECTOSCOPES | FJL | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 22, 1995 | K953771 | OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 6, 1995 | K953809 | KARL STORZ TAKE-APART BIOPOLAR FORCEPS | HET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 3, 1995 | K954910 | KARL STORZ OPTICAL MEDIASTINOSCOPE | EWY | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 26, 1995 | K953596 | DISTENDING DIVERTICULOSCOPE | EOQ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 30, 1995 | K943713 | TORCARS,CANNULAE,SHEATHS,OBTURATORS | HET | Substantially Equivalent | Karl Storz Endoskop GmbH | accessdata.fda.gov |
| June 14, 1995 | K951190 | KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE | HET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 9, 1995 | K951986 | INSULATED ELECTROSURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 25, 1995 | K943052 | ARTHROSCOPIC TELESCOPES | HRX | Substantially Equivalent | Karl Storz Endoscopy | accessdata.fda.gov |
| May 24, 1995 | K951995 | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR | KNY | Substantially Equivalent | Karl Storz Endoskop GmbH | accessdata.fda.gov |
| May 16, 1995 | K951625 | KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 12, 1995 | K945907 | KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES | FGC | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| April 3, 1995 | K951251 | KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| March 30, 1995 | K945211 | KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE | HET | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| March 29, 1995 | K950434 | KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES | OCZ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| February 9, 1995 | K944862 | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES | KNF | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| February 7, 1995 | K950125 | KARL STORZ BOUGIES AND DILATORS | FAX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 24, 1995 | K944793 | KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES | KNF | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 18, 1995 | K945381 | NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 21, 1994 | K945237 | KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE | EOX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 15, 1994 | K945751 | KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 6, 1994 | K943154 | KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS | HRX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 22, 1994 | K944797 | KARL STORZ INSULATED CANNULAE, SUCTION TUBES | EOB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 16, 1994 | K945380 | KARL STORZ MONOPOLAR HIGH FREQUENCY CORDS | GEI | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 9, 1994 | K945059 | KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| November 7, 1994 | K943435 | CHOLANGIOGRAPHY SET | GCJ | Substantially Equivalent | Karl Storz Endoskop GmbH | accessdata.fda.gov |
| November 2, 1994 | K944823 | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES | GEI | Substantially Equivalent | Karl Storz Endoskop GmbH | accessdata.fda.gov |
| September 21, 1994 | K943668 | KSEA CONTINOUS FLOW CYSTOSCOPE | FBO | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 20, 1994 | K944224 | KARL STORZ FLUID LIGHT CABLES | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 16, 1994 | K942786 | KARL STORZ LASER ACCESSORIES | GEX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| September 7, 1994 | K940427 | KARL STORZ THORACIC SURGERY INSTRUMENTS | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 24, 1994 | K943816 | TROCARS,CANNULAE, SHEATHS | EOB | Substantially Equivalent | Karl Storz Endoskop GmbH | accessdata.fda.gov |
| August 23, 1994 | K943700 | KARL STORZ BRONCHOSCOPE ACCESSORIES | EOQ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 18, 1994 | K943667 | ESOPHAGOSCOPE AND ACCESSORIES | EOX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 15, 1994 | K942612 | KARL STORZ WOUND CLOSURE INSTRUMENTS | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 24, 1994 | K940464 | KARL STORZ URETERO-RENOSCOPE/URETERSCOPE | FGB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| June 20, 1994 | K936036 | KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION | GEI | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 12, 1994 | K940346 | SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| March 23, 1994 | K934937 | KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC | GCJ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 25, 1994 | K935070 | GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS | FCL | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| January 11, 1994 | K934730 | KARL STORZ ENDOSCOPIC COLD KNIFE BLADES | EZO | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 18, 1993 | K925128 | THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE | FGB | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 4, 2008 | P050028 | COBAS TAQMAN HBV TEST | MKT | 88 | October 4, 2024 | accessdata.fda.gov |
| December 12, 2002 | P020008 | KARL STORZ AUTOFLUORESCENCE SYSTEM | MRK | 2 | December 23, 2009 | accessdata.fda.gov |
Compare with other makers
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- All makers of Esophagoscope (Flexible Or Rigid)
Updated October 4, 2024. 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.