Cleared Special

Instinct Plus Endoscopic Clipping Device

K212323 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology

Aug 2021

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K212323 is an FDA 510(k) clearance for the Instinct Plus Endoscopic Clipping Device, a Hemostatic Metal Clip For The Gi Tract (Class II — Special Controls, product code PKL), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on August 25, 2021, 30 days after receiving the submission on July 26, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number	K212323 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2021
Decision Date	August 25, 2021
Days to Decision	30 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

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.