510(k) K202430
K202430 is an FDA 510(k) premarket notification submitted by Kerecis Limited for the device "Kerecis Reconstruct". The FDA issued a decision of Substantially Equivalent on May 2, 2021. The device falls under product code OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery), a Class II device regulated under 21 CFR 878.3300. Kerecis Limited has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2021
- Date Received
- August 25, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.