K254069
- 510(k) number
- K254069
- Device name
- Hemoclip (511 series, 543 series)
- Applicant
- Hangzhou AGS MedTech Co., Ltd. CN
- Product code
- PKL — Hemostatic Metal Clip For The Gi Tract
- Decision date
- 2026-08-10
- Date received
- 2025-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K254069.pdf
Official FDA record: K254069
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.