SterilContainer S System
510(k) K162815
SterilContainer S System is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K162815 on 13 Jul 2017, 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 | NumberK162815 | Date13 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K162815
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KCT
- 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 KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).
- THE ULTRA SYSTEM SP by Promedica, Inc.
- ERMIS ER100.050E by Ermis MedTech GmbH
- KIT SAFE DRILL KESD 02 by S.I.N. - Sistema DE Implante Nacional S.A.
- Straumann® ProClean™ Cassette (041.800 ; 041.801) Storage Systems / Cassettes by Institut Straumann AG
- SURGICAL KIT KCSU 03 by S.I.N. - Sistema DE Implante Nacional S.A.
- HARKEN ASSURE SELF-SEAL STERILIZATION POUCH by Harken Products, Inc.
- 9102763030 9102-763-030 by Stryker Corp.
- UroLift System Rigid Retrieval Kit Sterilization Tray by Neotract, Inc.
- SKELETAL DYNAMICS STERILIZATION TRAYS by SKELETAL DYNAMICS, INC
- Stryker Universal Select Sterilization Tray System by Paragon Medical Inc.