Cleared Traditional

gastroduodenal FTRD Set

K200684 · Ovesco Endoscopy AG · Gastroenterology & Urology

Jun 2020

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K200684 is an FDA 510(k) clearance for the gastroduodenal FTRD Set, a Hemostatic Metal Clip For The Gi Tract (Class II — Special Controls, product code PKL), submitted by Ovesco Endoscopy AG (Tuebingen, DE). The FDA issued a Cleared decision on June 2, 2020, 78 days after receiving the submission on March 16, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number	K200684 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2020
Decision Date	June 02, 2020
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	PKL — Hemostatic Metal Clip For The Gi Tract
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.4400
Definition	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 Tubes, Supplemental Closure Method Of Luminal Perforations.