K241005
- 510(k) number
- K241005
- Device name
- Haemostasis Clips
- Applicant
- Jiangxi Zhuoruihua Medical Instrument Co., Ltd. CN
- Product code
- PKL — Hemostatic Metal Clip For The Gi Tract
- Decision date
- 2025-01-02
- Date received
- 2024-04-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K241005.pdf
Official FDA record: K241005
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.