Sutter Medizintechnik GmbH
Medical device manufacturer in Emmendingen, DE.
9510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251813 | CURIS II RF Generator (REF 360100-05)GEI · Traditional | 02/11/2026SE |
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes…GEI · Traditional | 01/25/2024SE |
| K193587 | Sutter Swyng non-stick bipolar forceps, single-useGEI · Traditional | 02/10/2020SE |
| K192128 | Sutter Arrowtip Monopolar ElectrodesGEI · Traditional | 10/04/2019SE |
| K191732 | Sutter RaVoR Bipolar ElectrodesGEI · Traditional | 08/30/2019SE |
| K171869 | Sutter CURIS RF GeneratorGEI · Traditional | 02/23/2018SE |
| K150959 | Sutter Bipolar Forceps-CalvianGEI · Traditional | 09/10/2015SE |
| K131012 | Sutter Bipolar Forceps - SuperglissGEI · Traditional | 08/23/2013SE |
| K073450 | Sutter Electrosurgical CablesGEI · Traditional | 03/17/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2744-2020 Class II | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical…The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and… | 06/23/2020Terminated |