510(k) K142656
K142656 is an FDA 510(k) premarket notification submitted by Covidien for the device "Surgical Gut Suture". The FDA issued a decision of Substantially Equivalent on January 29, 2015. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830. Covidien has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2015
- Date Received
- September 18, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Natural
- Device Class
- Class II
- Regulation Number
- 878.4830
- Review Panel
- SU
- Submission Type