SterilContainer S2 System
510(k) K193582
SterilContainer S2 System is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K193582 on 17 Mar 2020, 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 | NumberK193582 | Date17 Mar 2020 | StatusActive |
Official records
- FDA 510(k) database K193582
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- Withdrawn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
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