Amsco
The AMSCO 400 Series Prevacuum Steam Sterilizers are designed for sterilization of materials used in healthcare facilities. The AMSCO 400 Series Prevacuum Steam Sterilizers are equipped…
The AMSCO 400 Series Prevacuum Steam Sterilizers are designed for sterilization of materials used in healthcare facilities. The AMSCO 400 Series Prevacuum Steam Sterilizers are equipped with Prevacuum, gravity, leak test, and daily air removal test cycles. An optional Steam Flush Pressure Pulse (SFPP) configuration sterilizer adds SFPP cycles.
3manufacturers in China registered for this device type
434catalogue numbers in this listing
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 | Steris Mexico, S. de R.L. de C.V., Mexico |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K111223 |
| Record published | 2021-04-16 |
| Record revised | 2023-06-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Sizes | Length 36 to 38 in; width 20 to 26 in; height 20 to 37.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AX067111 | Length 36 in | In distribution |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| 16S | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| 16CS | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| 20CS | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| 600 | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| 60SL | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| 48SL | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| 16 | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| 48H | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| 36SL | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| 20C | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 400 Steam Sterilizer | In distribution | |
| AMSCO 600 Steam Sterilizer | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Bravo 21V Autoclave | Scican Ltd. | 17 |
Showing 12 of 119. All products under Sterilizer, Steam
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Steris Corporation | 510(k) number | 2019-10-22 | Class II | Process control | The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward | 237 units | 2020-06-09 |
| Steris Corporation | 510(k) number | 2015-09-03 | Class III | Software design | In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door. | 32 units | 2016-01-22 |
| Steris Corporation | 510(k) number | 2015-02-19 | Class II | Software design (manufacturing process) | STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a pr | 701 units | 2016-01-20 |
| Steris Corporation | 510(k) number | 2013-02-12 | Class II | Software design | The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used | 395 Units | 2013-12-05 |
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.