K261484
- 510(k) number
- K261484
- Device name
- Tissue Approximation System
- Applicant
- Tas Medical, Inc. FL · US
- Product code
- GAR — Suture, Nonabsorbable, Synthetic, Polyamide
- Decision date
- 2026-06-03
- Date received
- 2026-05-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K261484.pdf
Official FDA record: K261484
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.