K222944
- 510(k) number
- K222944
- Device name
- SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
- Applicant
- Safepath Medical, Inc. MA · US
- Product code
- GAP — Suture, Nonabsorbable, Silk
- Decision date
- 2024-10-18
- Date received
- 2022-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K222944.pdf
Official FDA record: K222944
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.