# Sutter Medizintechnik GmbH

- Location (FDA's records): Freiburg, DE
- FDA decisions: 9 (2008–2026): 9 510(k) clearances
- Product codes: GEI (9)
- 510(k) review time since 2016: median 85 days, against 99 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Celon AG Medical Instruments: 1 (https://510kreport.com/company/celon-ag-medical-instruments)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Egon Faulhaber Surgical Instruments Pinzetten: 1 (https://510kreport.com/company/egon-faulhaber-surgical-instruments-pinzetten)
- Guenter Bissinger Medizintechnik GmbH: 1 (https://510kreport.com/company/guenter-bissinger-medizintechnik)
- Xomed, Inc.: 1 (https://510kreport.com/company/xomed)
- Elliquence, LLC: 1 (https://510kreport.com/company/elliquence)

## Firms that cite its devices most
- Olsen Medical: 1 (https://510kreport.com/company/olsen-medical)
- Gunter Bissinger Medizintechnik GmbH: 1 (https://510kreport.com/company/gunter-bissinger-medizintechnik)
- KLS-Martin L.P.: 1 (https://510kreport.com/company/kls-martin)
- Hg Innovations, Ltd.: 1 (https://510kreport.com/company/hg-innovations)
- Guenter Bissinger Medizintechnik GmbH: 1 (https://510kreport.com/company/guenter-bissinger-medizintechnik)
- Medagent, Inc.: 1 (https://510kreport.com/company/medagent)

## Its most-cited devices
- K073450: Sutter Electrosurgical Cables (2008), cited by 4
- K193587: Sutter Swyng non-stick bipolar forceps, single-use (2020), cited by 1
- K150959: Sutter Bipolar Forceps-Calvian (2015), cited by 1
- K171869: Sutter CURIS RF Generator (2018), cited by 1

## Recent decisions
- K251813: CURIS II RF Generator (REF 360100-05) (Feb 11, 2026)
- K233425: FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) (Jan 25, 2024)
- K193587: Sutter Swyng non-stick bipolar forceps, single-use (Feb 10, 2020)
- K192128: Sutter Arrowtip Monopolar Electrodes (Oct 4, 2019)
- K191732: Sutter RaVoR Bipolar Electrodes (Aug 30, 2019)
- K171869: Sutter CURIS RF Generator (Feb 23, 2018)
- K150959: Sutter Bipolar Forceps-Calvian (Sep 10, 2015)
- K131012: Sutter Bipolar Forceps - Supergliss (Aug 23, 2013)

Source page: https://510kreport.com/company/sutter-medizintechnik