K250066
- 510(k) number
- K250066
- Device name
- Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- PKL — Hemostatic Metal Clip For The Gi Tract
- Decision date
- 2025-02-06
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250066.pdf
Official FDA record: K250066
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.