Sterilcontainer System
510(k) K112671
Sterilcontainer System is a Class II device made by Aesculap, Ltd., cleared under FDA 510(k) K112671 on 4 May 2012, 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 | NumberK112671 | Date4 May 2012 | StatusActive |
Official records
- FDA 510(k) database K112671
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- Withdrawn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
Devices cleared under K112671
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 59-0010-01 | 59-0010-01 / 59-0010-01 | 00841036211202 | — | On the market |
| 59-0010-02 | 59-0010-02 / 59-0010-02 | 00841036211219 | — | On the market |
| 59-0034-01 | 59-0034-01 / 59-0034-01 | 00841036211226 | — | On the market |
| 59-0034-02 | 59-0034-02 / 59-0034-02 | 00841036211233 | — | On the market |
| 59-0070-01 | 59-0070-01 / 59-0070-01 | 00841036211240 | — | On the market |
| 59-0070-02 | 59-0070-02 / 59-0070-02 | 00841036211257 | — | On the market |
| 59-0071-01 | 59-0071-01 / 59-0071-01 | 00841036211264 | — | On the market |
| 59-0074-01 | 59-0074-01 / 59-0074-01 | 00841036211271 | — | On the market |
| 59-0081-01 | 59-0081-01 / 59-0081-01 | 00841036211288 | — | On the market |
| 59-0081-02 | 59-0081-02 / 59-0081-02 | 00841036211295 | — | On the market |
Similar devices
Other devices filed under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).
- SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM by Sklar Corporation
- SURGICAL INSTRUMENT SXPS 02 by S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT KRFU by S.I.N. - Sistema DE Implante Nacional S.A.
- CONMED VP1003 by Conmed Corporation
- Instru-Safe Instrument Protection System by Summit Medical, LLC
- 9102550130 9102-550-130 by Stryker Corp.
- NUVO Implant System – NUVO Instrument Kit Cases by JJGC Indústria e Comércio de Materiais Dentários S/A.
- AUTOPAK STERILIZATION POUCH by Ongard Meddevice Packaging, Inc.
- Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator by Advanced Sterilization Products, Inc.
- Endoscope Sterilization Tray by Intuitive Surgical, Inc.