DeviceClearance

Hemoclip (511 series, 543 series)— 510(k) K254069

Substantially Equivalent

Hangzhou AGS MedTech Co., Ltd.

FDA 510(k) clearance K254069 for Hemoclip (511 series, 543 series), Substantially Equivalent on 2026-08-10. Applicant: Hangzhou AGS MedTech Co., Ltd.. Device class: 2.

Summary

Hangzhou AGS MedTech's Hemoclip comes in two listed series, 511 and 543. It's filed under product code PKL, hemostatic metal clips for the GI tract.

Class II, 21 CFR 876.4400. Gastroenterology and Urology is both the classification panel and the review panel, and it was a Traditional 510(k).

AGS MedTech filed from Hangzhou, China. The decision came 235 calendar days after FDA received it (December 18, 2025 to August 10, 2026), and it was substantially equivalent.

Clearance details

Applicant
Hangzhou AGS MedTech Co., Ltd.
Product code
Product code PKL
Device class
Class 2
Regulation
21 CFR 876.4400
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PKL

product code PKL
Death
9
Injury
489
Malfunction
4,698
Other
1
Total
5,197

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.