Data / Medical devices / Germany / Gimmi GMBH
Gimmi GMBH: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 18 510(k) clearances
Gimmi GMBH is registered with the FDA (registration 9612074) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 108 device types. The FDA files 18 510(k) clearances under its listings, the newest dated February 23, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612074
- FEI number
- 3002807072
- Address
- Carl-Zeiss-Strasse 6, TUTTLINGEN Baden-Wurttemberg, Germany, D-78532
- Owner or operator
- GIMMI GMBH (8010570)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- September 27, 1983
- Registered through
- 2026
- Brand names listed
- Arthroscope, CLAMP, PENILE, Clamp, Endoscope, GIMMI, Gimmi, Gimmi nasal knifes, Laparoscope and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Amniotome | HGE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Applier, Surgical, Clip | GDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carrier, Ligature | GEJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Nasal | KAN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Non-Electrical | FFN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Penile | FHA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Confocal Optical Imaging | OWN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Curette | HTF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Adenoid | KBJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Uterine | HCY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Tracheal | KCG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Manufacturer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dissector, Tonsil | KBM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrode, Electrosurgical, Active, Urological | FAS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Elevator | HTE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemostat | HRQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Tracheal | KCH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ear | JYO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Nasal | KAS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Light Source, Fiberoptic, Routine | FCW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nipper, Malleus | JYR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Otoscope | ERA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pick, Microsurgical Ear | JYT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pinwheel | GWY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe And Director, Gastro-Urology | FGM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Rectal, Non-Powered | EXX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ring Cutter | FNS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Episiotomy | HDK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Umbilical | HDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scoop | FHL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Screw, Fibroid, Gynecological | HHO | 2 | Manufacturer | accessdata.fda.gov |
| Snare, Tonsil | KBZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stripper, Surgical | HRT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tenaculum, Uterine | HDC | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Urethrotome | EZO | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|
| February 23, 2023 | K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | GCJ | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| June 8, 2018 | K173070 | HSW Resection Instruments | HIH | Substantially Equivalent | Henke-Sass, Wolf GmbH | accessdata.fda.gov |
| December 7, 2017 | K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath | FAJ | Substantially Equivalent | Henke-Sass, Wolf GmbH | accessdata.fda.gov |
| February 20, 2015 | K150024 | Bissinger Monopolar Cables | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| December 5, 2014 | K143221 | Schoelly Laparoscope | GCJ | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
| May 14, 2013 | K123077 | VASCULAR CLAMPS | DXC | Substantially Equivalent | Hebumedical GmbH | accessdata.fda.gov |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| July 19, 2006 | K060233 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIES | GCJ | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| July 12, 2006 | K060232 | TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES | GEI | Substantially Equivalent | Trokamed GmbH | accessdata.fda.gov |
| March 24, 2005 | K050163 | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| March 11, 2004 | K033177 | POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX | HET | Substantially Equivalent | Gunter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| March 11, 2002 | K012869 | GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 | HIH | Substantially Equivalent | Gimmi GmbH | accessdata.fda.gov |
| August 13, 1998 | K981751 | SINUSCOPE AND ACCESSORIES | EOB | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| August 6, 1998 | K981919 | BISSINGER CABLES, CAT. NO. 801000XX | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| May 21, 1998 | K970968 | BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS | HET | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| December 5, 1994 | K945474 | SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER | GCJ | Substantially Equivalent | Scanlan Intl., Inc. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 23, 2023. 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.