Data / Medical devices / Germany / Sutter Medizintechnik GMBH
Sutter Medizintechnik GMBH: FDA-registered device maker in Emmendingen Baden-Wurttemberg, Germany, 9 510(k) clearances
Sutter Medizintechnik GMBH is registered with the FDA (registration 8044091) in Emmendingen Baden-Wurttemberg, Germany. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 11, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8044091
- FEI number
- 3004857377
- Address
- Alfred-Walz-Strasse 22, Emmendingen Baden-Wurttemberg, Germany, D-79312
- Owner or operator
- Sutter Medizintechnik GmbH (9005453)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- January 22, 1997
- Registered through
- 2026
- Brand names listed
- Bipolar cable, SUTTER Electrosurgical Cables
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Manufacturer | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Contract manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 11, 2026 | K251813 | CURIS II RF Generator (REF 360100-05) | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| January 25, 2024 | K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| February 10, 2020 | K193587 | Sutter Swyng non-stick bipolar forceps, single-use | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| October 4, 2019 | K192128 | Sutter Arrowtip Monopolar Electrodes | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| August 30, 2019 | K191732 | Sutter RaVoR Bipolar Electrodes | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| February 23, 2018 | K171869 | Sutter CURIS RF Generator | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| September 10, 2015 | K150959 | Sutter Bipolar Forceps-Calvian | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| August 23, 2013 | K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| March 17, 2008 | K073450 | SUTTER ELECTROSURGICAL CABLES | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 23, 2020 | 86035 | Class II | Terminated | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengt | The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization using irradiation. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Lavage, Jet
- All makers of Nasopharyngoscope (Flexible Or Rigid)
- All makers of Arthroscope
- All makers of Tray, Surgical, Instrument
Updated February 11, 2026. 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.