Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sutter Medizintechnik GmbH with 9 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Feb 11, 2026: CURIS II RF Generator (REF 360100-05).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 11, 2026 | CURIS II RF Generator (REF 360100-05)K251813 · GEI | 510(k) clearances |
| Jan 25, 2024 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)K233425 · GEI | 510(k) clearances |
| Jun 23, 2020 | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with baClass II · The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C | Device recalls |
| Feb 10, 2020 | Sutter Swyng non-stick bipolar forceps, single-useK193587 · GEI | 510(k) clearances |
| Oct 4, 2019 | Sutter Arrowtip Monopolar ElectrodesK192128 · GEI | 510(k) clearances |
| Aug 30, 2019 | Sutter RaVoR Bipolar ElectrodesK191732 · GEI | 510(k) clearances |
| Feb 23, 2018 | Sutter CURIS RF GeneratorK171869 · GEI | 510(k) clearances |
| Sep 10, 2015 | Sutter Bipolar Forceps-CalvianK150959 · GEI | 510(k) clearances |
| Aug 23, 2013 | SUTTER BIPOLAR FORCEPS - SUPERGLISSK131012 · GEI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
