510(k) K241486
K241486 is an FDA 510(k) premarket notification submitted by Covidien for the device "Sofsilk Coated Braided Silk Suture". The FDA issued a decision of Substantially Equivalent on December 3, 2024. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Covidien has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2024
- Date Received
- May 24, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Silk
- Device Class
- Class II
- Regulation Number
- 878.5030
- Review Panel
- SU
- Submission Type