Statim 2000 G4 Cassette
by Scican Ltd
510(k) K112872
Statim 2000 G4 Cassette is a Class II device made by Scican Ltd, cleared under FDA 510(k) K112872 on 10 Jul 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 | NumberK112872 | Date10 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K112872
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FLE
- FDA applicant
- Scican , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6880
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K112872
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 | |||
|---|---|---|---|---|
| STATIM 2000 G4 Cassette Autoclave G4-121101 | G4-121101 / G4-121101 | 07640397421410 | — | On the market |
| STATIM 2000 G4 Cassette Autoclave G4-121101-L | G4-121101-L / G4-121101-L | 07640397421427 | — | On the market |
| STATIM 2000 G4 Cassette Autoclave G4-121101-R | G4-121101-R / G4-121101-R | 07640397421434 | — | On the market |
| STATIM 5000 G4 Cassette Autoclave G4-201103 | G4-201103 / G4-201103 | 07640397421588 | — | On the market |
| STATIM 5000 G4 Cassette Autoclave G4-201103-L | G4-201103-L / G4-201103-L | 07640397421595 | — | On the market |
| STATIM 5000 G4 Cassette Autoclave G4-201103-R | G4-201103-R / G4-201103-R | 07640397421601 | — | On the market |
| STATIM 5000 G4 Cassette Autoclave G4-211103 | G4-211103 / G4-211103 | 07540196003179 | — | No longer on the market |
| STATIM 5000 G4 Cassette Autoclave G4-211103 | G4-211103 / G4-211103 | 07640397421663 | — | On the market |
| STATIM 5000 G4 Cassette Autoclave G4-211103-L | G4-211103-L / G4-211103-L | 07540196003186 | — | No longer on the market |
| STATIM 5000 G4 Cassette Autoclave G4-211103-L | G4-211103-L / G4-211103-L | 07640397421670 | — | On the market |
| STATIM 5000 G4 Cassette Autoclave G4-211103-R | G4-211103-R / G4-211103-R | 07540196003193 | — | No longer on the market |
| STATIM 5000 G4 Cassette Autoclave G4-211103-R | G4-211103-R / G4-211103-R | 07640397421687 | — | On the market |
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