K251562
- 510(k) number
- K251562
- Device name
- OTSCneo System Set (100.03n-14n, 100.27n-31n)
- Applicant
- Ovesco Endoscopy AG DE
- Product code
- PKL — Hemostatic Metal Clip For The Gi Tract
- Decision date
- 2025-12-18
- Date received
- 2025-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K251562.pdf
Official FDA record: K251562
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.