K253620
- 510(k) number
- K253620
- Device name
- TroClose 1200
- Applicant
- Gordian Surgical, Ltd. IL
- Product code
- GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
- Decision date
- 2025-12-16
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253620.pdf
Official FDA record: K253620
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.