Amsco V-PRO
The Amsco V-PRO 1 Plus Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical…
The Amsco V-PRO 1 Plus Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices used in Healthcare Facilities.
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Incote Precision Machinery Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Steris Mexico, S. de R.L. de C.V., Mexico |
|---|---|
| FDA product code | MLR |
| Device type | Sterilizer, Chemical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6860 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K102330 |
| Record published | 2021-04-16 |
| Record revised | 2021-08-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-03-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V-PRO maX | Withdrawn | |
| 1 Plus | Withdrawn | |
| maX | Withdrawn | |
| 1 | Withdrawn | |
| V-PRO maX | Withdrawn | |
| V-PRO maX | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trilogy® | Zimmer, Inc. | 274 |
| Sterrad™ | Advanced Sterilization Products Services Inc. | 18 |
| NexGen® | Zimmer, Inc. | 15 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 10 |
| V-PRO | Steris Mexico, S. de R.L. de C.V. | 7 |
| SteroScope Insert Connector Large Assembly, Type 3, Qty 1 | Ideate Medical | 4 |
| Vaprox | Steris Corporation | 4 |
| Sterilink™ | Plasmapp Co., Ltd. | 3 |
| SteroScope Insert Connector Extra Small Assembly, Type R2, Qty 1 | Ideate Medical | 2 |
| Sterlink™ | Plasmapp Co., Ltd. | 2 |
| SteroScope Biopsy Connector Assembly, Type R1, Qty 1 | Ideate Medical | 2 |
| Sterrad NX™ | Advanced Sterilization Products Services Inc. | 2 |
Showing 12 of 34. All products under Sterilizer, Chemical
Recalls Naming This Product
3 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 | 2018-07-26 | Class II | Software design | There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run. | 2889 units | 2020-03-30 |
| Steris Corporation | 510(k) number | 2017-09-28 | Class II | Device Design | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle. | 406 | 2018-09-12 |
| Steris Corporation | 510(k) number | 2011-08-01 | Not classified | Other | STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device’ | 663 units | 2013-03-27 |
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.