Convertors Sterilization Wrap
510(k) K921243
Convertors Sterilization Wrap is a Class II device made by Baxter Healthcare Corp, cleared under FDA 510(k) K921243 on 28 Oct 1992, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921243 | Date28 Oct 1992 | StatusActive |
Official records
- FDA 510(k) database K921243
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRG
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code FRG (Wrap, Sterilization).
- PRO-GUARD by Surgicot, Inc.
- WRAPPEL T by STANDARD TEXTILE CO., INC.
- AESCULAP STERILCONTAINER S by AESCULAP, INC.
- MEDI-SEAL STERILIZATION POUCHES & TUB by Medical Industries Packaging, Inc.
- Sterilization Pouch/Roll Made with Tyvek by Sigma Medical Supplies Corp.
- STERILIZATION POUCH WITH INDICATORS by Winner Industries (Shenzhen) Co., Ltd.
- STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS by CASE MEDICAL INC
- Sterisheet Sterilization Wrap by Andersen Sterilizers, Inc.
- CARAPACE DEBRIDEMENT KITS by Carapace, Inc.
- BIOPSY TRAY by Medcare Medical Group, Inc.