Hemoclip— 510(k) K252270

Name: FDA 510(k) clearance K252270
Creator: U.S. Food and Drug Administration
Published: 2026-04-08

Substantially Equivalent

Hangzhou AGS MedTech Co., Ltd.

FDA 510(k) clearance K252270 for Hemoclip, Substantially Equivalent on 2026-04-08. Applicant: Hangzhou AGS MedTech Co., Ltd.. Device class: 2.

Summary

Hemoclip is an endoscopic clip under PKL, hemostatic metal clips for the GI tract. Gastroenterologists deploy these through an endoscope to stop bleeding and close defects, for example after polyp removal.

Class II, 21 CFR 876.4400. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).

Hangzhou AGS MedTech filed from Hangzhou, China. Review took 261 days (July 21, 2025 to April 8, 2026). The name is generic, and the record doesn't give clip sizes or other design details.

Clearance details

Applicant: Hangzhou AGS MedTech Co., Ltd.
Product code: Code PKL
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2025-07-21
Decision date: 2026-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKL

view all

K254069 — Hemoclip (511 series, 543 series)2026-08-10
K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more2026-05-21
K253734 — Taurus Clip2026-03-12
K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)2025-12-18
K252271 — Hemoclip2025-11-12

More clearances from Hangzhou AGS MedTech Co., Ltd.

view all

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, 2020-01-01 through 2026-04-23. 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.