TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
510(k) K192389
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192389 | Date27 Mar 2020 | StatusActive |
Official records
- FDA 510(k) database K192389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FTL
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The TYRX Absorbable Antibacterial Envelope is a mesh, surgical, polymeric device used with cardiac implantable electronic devices, including implantable cardioverter defibrillators. The envelope contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pacemaker or defibrillator.
The device is supplied in medium and large sizes and is designed to be absorbable. It is regulated under product code FTL with regulation number 878.3300 and was determined to be substantially equivalent by the FDA in 2020. The device is intended for use in general and plastic surgery applications.