Cleared Special

Padlock Clip defect closure device (K180689) - FDA 510(k) Clearance

Also marketed or referenced as:
Padlock Clip Pro-Select defect closure device

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180689 · STERIS Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
28d
Days
Class 2
Risk

K180689 is an FDA 510(k) clearance for the Padlock Clip defect closure device. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 12, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all STERIS Corporation devices

Submission Details

510(k) Number K180689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2018
Decision Date April 12, 2018
Days to Decision 28 days
Submission Type Special
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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 52
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K180689.
SureClip Repositionable Hemostasis Clip
K182556 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2018
Single Use MultiClip Device
K180325 · Micro-Tech (Nanjing) Co., Ltd. · Jun 2018
Hemoclip
K172727 · Hangzhou AGS MedTech Co., Ltd. · Apr 2018
Single Use Hemoclip
K172762 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2018
Resolution Clip
K151802 · Boston Scientific Corporation · Aug 2015
Resolution Clip
K142973 · Boston Scientific Corporation · Dec 2014