K253910
- 510(k) number
- K253910
- Device name
- Stitch - Suture Wires and Tapes
- Applicant
- GM Dos Reis Industria e Comercio Ltda. BR
- Product code
- GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
- Decision date
- 2026-08-22
- Date received
- 2025-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253910.pdf
Official FDA record: K253910
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.