K242201
- 510(k) number
- K242201
- Device name
- HyperSuture White/Green Extension Line
- Applicant
- Threadstone, LLC MD · US
- Product code
- GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
- Decision date
- 2025-03-27
- Date received
- 2024-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K242201.pdf
Official FDA record: K242201
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.