K252201
- 510(k) number
- K252201
- Device name
- HS Fiber
- Applicant
- Riverpoint Medical OR · US
- Product code
- GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
- Decision date
- 2025-08-13
- Date received
- 2025-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252201.pdf
Official FDA record: K252201
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.