510(k) K221280
K221280 is an FDA 510(k) premarket notification submitted by Lydus Medical , Ltd. for the device "Vesseal". The FDA issued a decision of Substantially Equivalent on December 9, 2022. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2022
- Date Received
- May 3, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Device Class
- Class II
- Regulation Number
- 878.5010
- Review Panel
- SU
- Submission Type