510(k) Report

FDA applicant

Ovesco Endoscopy AG

Tuebingen, DE16 decisions2010–20260 recalls

FDA records 16 decisions for Ovesco Endoscopy AG (Tuebingen, DE) from 2010 to 2026: 15 510(k) clearances and 1 De Novo grant. Most are in product codes PKL (Hemostatic Metal Clip For The Gi Tract) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 181 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Ovesco Endoscopy AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2010: 12014: 22015: 22016: 12017: 22019: 12020: 12022: 12024: 12025: 22026 (partial year): 2
2010high 2 (2014) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Ovesco Endoscopy AG by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ovesco Endoscopy AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PKLHemostatic Metal Clip For The Gi Tract10decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • OCXEndoscopic Irrigation/Suction System1decision
  • FDISnare, Flexible1decision
  • KGEForceps, Biopsy, Electric1decision
  • PLLSubmucosal Injection Agent1decision

Also: QAG (1).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 231 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 181 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K101428Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG · 20103cite it
  • K170867FTRD System SetOvesco Endoscopy AG · 20172cite it
  • K183309stentfix OTSC System SetOvesco Endoscopy AG · 20191cites it
  • K200684gastroduodenal FTRD SetOvesco Endoscopy AG · 20201cites it
  • K241858BARS Set (100.60)Ovesco Endoscopy AG · 20241cites it

What has FDA decided for it lately?

  • K260487stentFIX System Set (100.50n)Ovesco Endoscopy AG · 2026
  • K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)Ovesco Endoscopy AG · 2026
  • K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025
  • K242586ArgoCap (200.52)Ovesco Endoscopy AG · 2025
  • K241858BARS Set (100.60)Ovesco Endoscopy AG · 2024
  • K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)Ovesco Endoscopy AG · 2022
  • K200684gastroduodenal FTRD SetOvesco Endoscopy AG · 2020
  • K183309stentfix OTSC System SetOvesco Endoscopy AG · 2019

All 16 as Ovesco Endoscopy AG →