Sutter Medizintechnik GmbH is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Sutter Medizintechnik GmbH - FDA 510(k) Cleared Devices
Recent clearances: CURIS II RF Generator (REF 360100-05), FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035), Sutter Swyng non-stick bipolar forceps, single-use
9
Total
9
Cleared
0
Denied
Sutter Medizintechnik GmbH has 9 FDA 510(k) cleared medical devices. Based in Emmendingen, DE.
Latest FDA clearance: Feb 2026. Active since 2008. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Sutter Medizintechnik GmbH Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Visamed GmbH and Emergo Global Consulting, LLC.
FDA 510(k) Regulatory Record - Sutter Medizintechnik GmbH
9 devices
Cleared
Feb 11, 2026
CURIS II RF Generator (REF 360100-05)
General & Plastic Surgery
243d
Cleared
Jan 25, 2024
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar...
General & Plastic Surgery
106d
Cleared
Feb 10, 2020
Sutter Swyng non-stick bipolar forceps, single-use
General & Plastic Surgery
49d
Cleared
Oct 04, 2019
Sutter Arrowtip Monopolar Electrodes
General & Plastic Surgery
58d
Cleared
Aug 30, 2019
Sutter RaVoR Bipolar Electrodes
Ear, Nose, Throat
63d
Cleared
Feb 23, 2018
Sutter CURIS RF Generator
General & Plastic Surgery
246d
Cleared
Sep 10, 2015
Sutter Bipolar Forceps-Calvian
General & Plastic Surgery
153d
Cleared
Aug 23, 2013
SUTTER BIPOLAR FORCEPS - SUPERGLISS
General & Plastic Surgery
134d
Cleared
Mar 17, 2008
SUTTER ELECTROSURGICAL CABLES
General & Plastic Surgery
98d