510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101428Substantially Equivalent

Otsc (Over-the Scope-Clip) System Set

Ovesco Endoscopy AG, Karlsruhe, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101428 is the FDA 510(k) clearance record for OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET, a class II device, cleared for Ovesco Endoscopy AG on under FDA product code PKL (Hemostatic Metal Clip For The Gi Tract). FDA's definition for product code PKL reads: "Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding...". FDA records list 14 510(k) clearances for Ovesco Endoscopy AG, from to . As of , FDA records show no recalls naming K101428.

Clearance record

Decision date
Received
(194 days to decision)
Product code
PKL Hemostatic Metal Clip For The Gi Tract
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ovesco Endoscopy AG Kastellstr. 8, Karlsruhe, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PKL

Trailing 12 months
7 clearances under product code PKL in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PKL, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20261
September 20261
October 20260