Cleared Traditional

K193424 - Resolution 360 ULTRA Clip

K193424 is the FDA 510(k) clearance for Resolution 360 ULTRA Clip by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code PKL) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K193424 · Boston Scientific Corporation · Gastroenterology & Urology device
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Sep 2020
Decision
266d
Days
Class 2
Risk

K193424 is an FDA 510(k) clearance for the Resolution 360™ ULTRA Clip. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on September 1, 2020 after a review of 266 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K193424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2019
Decision Date September 01, 2020
Days to Decision 266 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
136d slower than avg
Panel avg: 130d · This submission: 266d
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 K193424.
X-Tack Endoscopic HeliX Tacking System
K201808 · Apollo Endosurgery, Inc. · Dec 2020
Single Use Rotatable and Repositionable Hemoclip
K201771 · Anrei Medical (Hangzhou) Co., Ltd. · Oct 2020
ClearEndoclip
K200217 · Finemedix Co., Ltd. · Oct 2020
gastroduodenal FTRD Set
K200684 · Ovesco Endoscopy AG · Jun 2020
Instinct Plus Endoscopic Clipping Device
K192697 · Cook Endoscopy · Mar 2020
Padlock Clip defect closure system, Padlock Pro-Select defect closure device
K192722 · STERIS Corporation · Oct 2019