K234079
- 510(k) number
- K234079
- Device name
- HyperSuture Extension Line
- Applicant
- Threadstone, LLC MD · US
- Product code
- GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
- Decision date
- 2024-05-10
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K234079.pdf
Official FDA record: K234079
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.