K230311
- 510(k) number
- K230311
- Device name
- HyperSuture
- Applicant
- Threadstone, LLC MD · US
- Product code
- GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
- Decision date
- 2023-11-24
- Date received
- 2023-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K230311.pdf
Official FDA record: K230311
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.