Medical Device Manufacturer · DE , Emmendingen

Sutter Medizintechnik GmbH

9 submissions · 9 cleared · Since 2008
9
Total
9
Cleared
0
Denied

Sutter Medizintechnik GmbH — FDA 510(k) Submissions

Sutter Medizintechnik GmbH has submitted 9 FDA 510(k) premarket notifications since 2008, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
CURIS II RF Generator (REF 360100-05)
K251813 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 2026 243d
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
K233425 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2024 106d
Sutter Swyng non-stick bipolar forceps, single-use
K193587 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 2020 49d
Sutter Arrowtip Monopolar Electrodes
K192128 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2019 58d
Sutter RaVoR Bipolar Electrodes
K191732 · GEI Electrosurgical, Cutting... · Ear, Nose, Throat
Aug 2019 63d
Sutter CURIS RF Generator
K171869 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 2018 246d
Sutter Bipolar Forceps-Calvian
K150959 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2015 153d
SUTTER BIPOLAR FORCEPS - SUPERGLISS
K131012 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 2013 134d
SUTTER ELECTROSURGICAL CABLES
K073450 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2008 98d
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