Sutter Medizintechnik GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2744-2020 | Class II | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. T | June 23, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251813 | CURIS II RF Generator (REF 360100-05) | February 11, 2026 |
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S98 | January 25, 2024 |
| K193587 | Sutter Swyng non-stick bipolar forceps, single-use | February 10, 2020 |
| K192128 | Sutter Arrowtip Monopolar Electrodes | October 4, 2019 |
| K191732 | Sutter RaVoR Bipolar Electrodes | August 30, 2019 |
| K171869 | Sutter CURIS RF Generator | February 23, 2018 |
| K150959 | Sutter Bipolar Forceps-Calvian | September 10, 2015 |
| K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS | August 23, 2013 |
| K073450 | SUTTER ELECTROSURGICAL CABLES | March 17, 2008 |