K231277
- 510(k) number
- K231277
- Device name
- TissueStat
- Applicant
- Durastat, LLC TX · US
- Product code
- NBY — Suture, Surgical, Nonabsorbable, Expanded, Polytetra
- Decision date
- 2023-11-09
- Date received
- 2023-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K231277.pdf
Official FDA record: K231277
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.