Ovesco Endoscopy AG is one of 467 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Ovesco Endoscopy AG - FDA 510(k) Cleared Devices
Recent clearances: stentFIX System Set (100.50n), colonic FTRD Set (200.70), OTSCneo System Set (100.03n-14n, 100.27n-31n)
16
Total
15
Cleared
1
Denied
Ovesco Endoscopy AG has 15 FDA 510(k) cleared gastroenterology & urology devices. Based in Karlsruhe, DE.
Latest FDA clearance: Oct 2026. Active since 2010.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Novineon CRO GmbH, Novineon Cro & Consulting, Ltd. and Novineon Cro. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Ovesco Endoscopy AG
16 devices
Cleared
Oct 02, 2026
stentFIX System Set (100.50n)
Gastroenterology & Urology
231d
Cleared
Sep 14, 2026
colonic FTRD Set (200.70)
Gastroenterology & Urology
335d
Cleared
Dec 18, 2025
OTSCneo System Set (100.03n-14n, 100.27n-31n)
Gastroenterology & Urology
210d
Cleared
May 22, 2025
ArgoCap (200.52)
Gastroenterology & Urology
265d
Cleared
Aug 26, 2024
BARS Set (100.60)
Gastroenterology & Urology
60d
Cleared
Aug 11, 2022
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
Gastroenterology & Urology
90d
Cleared
Jun 02, 2020
gastroduodenal FTRD Set
Gastroenterology & Urology
78d
Cleared
Oct 22, 2019
stentfix OTSC System Set
Gastroenterology & Urology
327d
Not Cleared
Dec 22, 2017
remOVE System
Gastroenterology & Urology
620d
Cleared
Jul 25, 2017
FTRD System Set
Gastroenterology & Urology
124d
Cleared
Oct 12, 2016
FTRD System Set
Gastroenterology & Urology
306d
Cleared
Sep 16, 2015
OTSC Proctology
Gastroenterology & Urology
246d