Cleared Traditional

K161463 - SureClip(TM) Repositionable Hemostasis Clip

K161463 is an FDA 510(k) clearance for SureClip(TM) Repositionable Hemostasis Clip, manufactured by Micro-Tech (Nanjing) Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code PKL cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K161463 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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Jan 2017
Decision
225d
Days
Class 2
Risk

K161463 is an FDA 510(k) clearance for the SureClip(TM) Repositionable Hemostasis Clip. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on January 6, 2017 after a review of 225 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 Micro-Tech (Nanjing) Co., Ltd. devices

FDA 510(k) Submission Details - K161463

510(k) Number K161463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2016
Decision Date January 06, 2017
Days to Decision 225 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
94d slower than avg
Panel avg: 131d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PKL Device Classification - Class 2, Special Controls

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 61
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K161463.
Padlock Clip defect closure device
K180689 · STERIS Corporation · Apr 2018
Single Use Hemoclip
K172762 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 2018
FTRD System Set
K170867 · Ovesco Endoscopy AG · Jul 2017
FTRD System Set
K153550 · Ovesco Endoscopy AG · Oct 2016
Sterile Repositionable Hemostasis Clipping Device
K152001 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2015
OTSC Proctology
K150067 · Ovesco Endoscopy AG · Sep 2015