510(k) clearance
Stitch - Suture Wires and Tapes
- 510(k) number
- K253910
- Applicant
- GM Dos Reis Industria e Comercio Ltda.
- Decision date
- Aug 22, 2026
- Date received
- Dec 8, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GAT
- Device type
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II
- Regulation
- 21 CFR 878.5000
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Campinas, BR