Cleared Traditional

K254069 - Hemoclip (511 series, 543 series)

K254069 is an FDA 510(k) clearance for Hemoclip (511 series, manufactured by Hangzhou AGS MedTech Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code PKL cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K254069 · Hangzhou AGS MedTech Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
235d
Days
Class 2
Risk

K254069 is an FDA 510(k) clearance for the Hemoclip (511 series, 543 series). 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 August 10, 2026 after a review of 235 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

FDA 510(k) Submission Details - K254069

510(k) Number K254069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2025
Decision Date August 10, 2026
Days to Decision 235 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
104d slower than avg
Panel avg: 131d · This submission: 235d
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 K254069.
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K260580 · Olympus Medical Systems Corp. · May 2026
Hemoclip
K252270 · Hangzhou AGS MedTech Co., Ltd. · Apr 2026
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
Dual Action Tissue Closure Device
K250229 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2025