K232969
- 510(k) number
- K232969
- Device name
- Disposable Hemostatic Clips
- Applicant
- Ningbo Xinwell Medical Technology Co., Ltd. CN
- Product code
- PKL — Hemostatic Metal Clip For The Gi Tract
- Decision date
- 2024-06-07
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232969.pdf
Official FDA record: K232969
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.