K-number	K252271
Device name	Hemoclip
Applicant	Hangzhou AGS MedTech Co., Ltd.
Product code	PKL
Device class	Class II
Decision date	Nov 12, 2025
Decision	Substantially Equivalent
Regulation	876.4400

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Hemoclip

Everything you need for a 510(k) submission. Nothing you don't.