510(k) K192389
K192389 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)". The FDA issued a decision of Substantially Equivalent on Mar 27, 2020. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Medtronic, Inc. has 247 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 2020
- Date Received
- Sep 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
- 510(k)