Hemoclip (511 series, 543 series) (K254069): 510(k) cleared Aug 10, 2026

Hemoclip (511 series, 543 series)

Hangzhou AGS MedTech Co., Ltd. · Aug 10, 2026 · K254069

FDA cleared the Hemoclip (511 series, 543 series) from Hangzhou AGS MedTech Co., Ltd. on Aug 10, 2026 under K254069, a traditional 510(k). The device falls under product code PKL, Hemostatic Metal Clip For The Gi Tract, regulated at 21 CFR 876.4400 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 18, 2025. The decision came 235 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hangzhou AGS MedTech Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K253393 (Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019), K252270 (Hemoclip), K252271 (Hemoclip).

Questions & Answers

What did FDA clear under K254069?

K254069 is the FDA 510(k) for Hemoclip (511 series, 543 series), submitted by Hangzhou AGS MedTech Co., Ltd.. FDA's decision date was Aug 10, 2026, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the Hemoclip (511 series, 543 series)?

Hangzhou AGS MedTech Co., Ltd., based in Hangzhou, is the applicant of record for K254069.

How long did the K254069 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Aug 10, 2026, 235 days later.

← All decisions in August 2026