K250229
- 510(k) number
- K250229
- Device name
- Dual Action Tissue Closure Device
- Applicant
- Micro-Tech (Nanjing) Co., Ltd. CN
- Product code
- PKL — Hemostatic Metal Clip For The Gi Tract
- Decision date
- 2025-09-08
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250229.pdf
Official FDA record: K250229
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.