Sutter Medizintechnik GmbH
Emmendingen Baden-Wurttemberg, DE
SUTTER MEDIZINTECHNIK GMBH appears in FDA device records in Emmendingen Baden-Wurttemberg, DE. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Sutter Medizintechnik GmbH between 2008 and 2026. The busiest year on record is 2019, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251813 | CURIS II RF Generator (REF 360100-05) | GEI | Substantially Equivalent | |
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | GEI | Substantially Equivalent | |
| K193587 | Sutter Swyng non-stick bipolar forceps, single-use | GEI | Substantially Equivalent | |
| K192128 | Sutter Arrowtip Monopolar Electrodes | GEI | Substantially Equivalent | |
| K191732 | Sutter RaVoR Bipolar Electrodes | GEI | Substantially Equivalent | |
| K171869 | Sutter CURIS RF Generator | GEI | Substantially Equivalent | |
| K150959 | Sutter Bipolar Forceps-Calvian | GEI | Substantially Equivalent | |
| K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS | GEI | Substantially Equivalent | |
| K073450 | SUTTER ELECTROSURGICAL CABLES | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8044091 | 3004857377 | SUTTER MEDIZINTECHNIK GMBH | Alfred-Walz-Strasse 22, Emmendingen Baden-Wurttemberg D-79312 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2744-2020 | 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 lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain