K253394
- 510(k) number
- K253394
- Device name
- Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- Applicant
- ETHICON, Inc. NJ · US
- Product code
- GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
- Decision date
- 2026-06-25
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253394.pdf
Official FDA record: K253394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.