Cleared Traditional

K192697 - Instinct Plus Endoscopic Clipping Device

K192697 is the FDA 510(k) clearance for Instinct Plus Endoscopic Clipping Device by Cook Endoscopy. It is a Class 2 Gastroenterology & Urology device (product code PKL) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K192697 · Cook Endoscopy · Gastroenterology & Urology device
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Mar 2020
Decision
161d
Days
Class 2
Risk

K192697 is an FDA 510(k) clearance for the Instinct Plus Endoscopic Clipping Device. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on March 5, 2020 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Endoscopy devices

Submission Details

510(k) Number K192697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date March 05, 2020
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKL Hemostatic Metal Clip For The Gi Tract
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PKL Hemostatic Metal Clip For The Gi Tract

All 54
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K192697.
ClearEndoclip
K200217 · Finemedix Co., Ltd. · Oct 2020
Resolution 360™ ULTRA Clip
K193424 · Boston Scientific Corporation · Sep 2020
gastroduodenal FTRD Set
K200684 · Ovesco Endoscopy AG · Jun 2020
Padlock Clip defect closure system, Padlock Pro-Select defect closure device
K192722 · STERIS Corporation · Oct 2019
stentfix OTSC System Set
K183309 · Ovesco Endoscopy AG · Oct 2019
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
K183590 · Olympus Medical Systems Corp. · Aug 2019