Cleared Traditional

FTRD System Set

K170867 · Ovesco Endoscopy AG · Gastroenterology & Urology

Jul 2017

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K170867 is an FDA 510(k) clearance for the FTRD System 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 July 25, 2017, 124 days after receiving the submission on March 23, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number	K170867 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2017
Decision Date	July 25, 2017
Days to Decision	124 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.