Medical Device Manufacturer · DE , Karlsruhe

Ovesco Endoscopy AG

14 submissions · 13 cleared · Since 2010
14
Total
13
Cleared
1
Denied

Ovesco Endoscopy AG — FDA 510(k) Submissions

Ovesco Endoscopy AG has submitted 14 FDA 510(k) premarket notifications since 2010, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hemostatic Metal Clip For The Gi Tract, Endoscopic Electrosurgical Clip Cutting System, Snare, Flexible, Electrosurgical, Cutting & Coagulation & Accessories, Forceps, Biopsy, Electric . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
OTSCneo System Set (100.03n-14n, 100.27n-31n)
K251562 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Dec 2025 210d
ArgoCap (200.52)
K242586 · OCX Endoscopic... · Gastroenterology & Urology
May 2025 265d
BARS Set (100.60)
K241858 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Aug 2024 60d
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
K221385 · PLL Submucosal Injection Agent · Gastroenterology & Urology
Aug 2022 90d
gastroduodenal FTRD Set
K200684 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jun 2020 78d
stentfix OTSC System Set
K183309 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Oct 2019 327d
remOVE System
DEN160014 · QAG Endoscopic... · Gastroenterology & Urology
Dec 2017 620d
FTRD System Set
K170867 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jul 2017 124d
FTRD System Set
K153550 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Oct 2016 306d
OTSC Proctology
K150067 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Sep 2015 246d
AQANIFE
K141790 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2015 247d
ENDO-MARYLAND DISSECTOR
K141794 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Nov 2014 140d
TRACTION POLYPECTOMY SNARE
K140923 · FDI Snare, Flexible · Gastroenterology & Urology
Nov 2014 222d
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
K101428 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Dec 2010 194d
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