Statim 2000 Cassette Autoclave
3 catalogue numbers from 01-121101, listed by Scican Ltd., Canada, under Sterilizer, Steam. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
3catalogue numbers in this listing
13510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Ningbo Ican Machines Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Scican Ltd., Canada |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Manufacturer, Exporter |
| Record published | 2016-08-02 |
| Record revised | 2023-06-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-06-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-121101 | Withdrawn | |
| 01-121101-L | Withdrawn | |
| 01-121101-R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amsco | Steris Mexico, S. de R.L. de C.V. | 434 |
| Getinge 500 Series | Getinge IC Production Poland sp. z o.o. | 133 |
| Getinge 700 Series | Getinge IC Production Poland sp. z o.o. | 82 |
| Aesculap | Aesculap AG | 67 |
| Getinge 600 Series | Getinge IC Production Poland sp. z o.o. | 61 |
| Sterilizer, Steam | Steris Mexico, S. de R.L. de C.V. | 53 |
| Getinge 800 Series | Getinge IC Production Poland sp. z o.o. | 41 |
| Getinge 400 Series | Getinge IC Production Poland sp. z o.o. | 37 |
| Primus Sterilizer | Primus Sterilizer Company, LLC. | 24 |
| Midmark | Midmark Corporation | 21 |
| Bravo 17V Autoclave | Scican Ltd. | 19 |
| Atlas | Steris Mexico, S. de R.L. de C.V. | 18 |
Showing 12 of 119. All products under Sterilizer, Steam
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K214057 | 2022-03-31 |
| K210326 | 2021-07-01 |
| K192910 | 2020-06-19 |
| K190062 | 2019-07-26 |
| K112872 | 2012-07-10 |
| K090265 | 2009-05-15 |
| K072466 | 2007-12-19 |
| K021064 | 2002-08-08 |
| K983679 | 1999-01-04 |
| K962179 | 1997-01-13 |
| K944036 | 1996-10-02 |
| K915054 | 1992-08-04 |
| K910241 | 1991-05-03 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-06-22 | Class II | Employee error | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medic | 19 units |
| 2023-06-22 | Class II | Employee error | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medic | 3 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.