Cleared Traditional

K252270 - Hemoclip (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252270 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
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Apr 2026
Decision
261d
Days
Class 2
Risk

K252270 is an FDA 510(k) clearance for the Hemoclip. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Hangzhou AGS MedTech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 8, 2026 after a review of 261 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 Hangzhou AGS MedTech Co., Ltd. devices

Submission Details

510(k) Number K252270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2025
Decision Date April 08, 2026
Days to Decision 261 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
131d slower than avg
Panel avg: 130d · This submission: 261d
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 61
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K252270.
Taurus Clip
K253734 · Taurus Endoscopy · Mar 2026
OTSCneo System Set (100.03n-14n, 100.27n-31n)
K251562 · Ovesco Endoscopy AG · Dec 2025
Hemoclip
K252271 · Hangzhou AGS MedTech Co., Ltd. · Nov 2025
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K250229 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2025
PADLOCK CLIP EFTR Kit (00713229)
K250842 · STERIS Corporation · Apr 2025
Resolution Clip (M00522600)
K250066 · Boston Scientific Corporation · Feb 2025