510(k) K222641
K222641 is an FDA 510(k) premarket notification submitted by Covidien for the device "Signia Small Diameter Reloads Including Regular (Round) Tip Version". The FDA issued a decision of Substantially Equivalent on November 29, 2022. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Covidien has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2022
- Date Received
- September 1, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type