Aesculap Sterilcontainer System
510(k) K053389
Aesculap Sterilcontainer System is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K053389 on 15 Feb 2006, 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 | NumberK053389 | Date15 Feb 2006 | StatusActive |
Official records
- FDA 510(k) database K053389
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- Withdrawn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).
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- Vis-U-All Low Temperature Sterilization Pouch/Tubing by STERIS CORPORATION
- DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION by Cardinal Health 200, LLC
- Standard Supreme Sterilization Wrapper by STANDARD TEXTILE CO., INC.
- CPR LACERATION TRAY by Custom Pack Reliability
- PRO-GUARD by Surgicot, Inc.
- WRAPPEL T by STANDARD TEXTILE CO., 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.