Evotech™
EVOTECH™ Endoscope Cleaner and Reprocessor (ECR)
1manufacturer
104catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Advanced Sterilization Products Services Inc. |
|---|---|
| FDA product code | FEB |
| Device type | Accessories, Cleaning, For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K082392 |
| Record published | 2016-09-24 |
| Record revised | 2025-12-23 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Distribution end date | 2023-01-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0845702 | In distribution | |
| 0848102 | In distribution | |
| 0111901 | In distribution | |
| 0910601 | In distribution | |
| 0114701 | In distribution | |
| 0900301 | In distribution | |
| 0845302 | In distribution | |
| 0842103 | In distribution | |
| 0940801 | In distribution | |
| 0102801 | In distribution | |
| 0913501 | In distribution | |
| 0945501 | In distribution | |
| 0900701 | In distribution | |
| 0900801 | In distribution | |
| 09414001 | In distribution | |
| 0904001 | In distribution | |
| 0103801 | In distribution | |
| 0114702 | In distribution | |
| 0105401 | In distribution | |
| 845301 | In distribution | |
| 0103003 | In distribution | |
| 0104102 | In distribution | |
| 0117201 | In distribution | |
| 0105501 | In distribution | |
| 0101901 | In distribution | |
| 0112501 | In distribution | |
| 0841502 | In distribution | |
| 0110801 | In distribution | |
| 50014 | In distribution | |
| 0120401 | In distribution | |
| 0848103 | In distribution | |
| 0120501 | In distribution | |
| 0841903 | In distribution | |
| 0104502 | In distribution | |
| 0103601 | In distribution | |
| 0900102 | In distribution | |
| 0103701 | In distribution | |
| 0112301 | In distribution | |
| 0117701 | In distribution | |
| 0117501 | In distribution | |
| 0906301 | In distribution | |
| 0117001 | In distribution | |
| 0103302 | In distribution | |
| 0849501 | In distribution | |
| 0103201 | In distribution | |
| 0102001 | In distribution | |
| 0945202 | In distribution | |
| 0112401 | In distribution | |
| 0841401 | In distribution | |
| 0905601 | In distribution | |
| 0841902 | In distribution | |
| 0101801 | In distribution | |
| 0102902 | In distribution | |
| 0105701 | In distribution | |
| 0120201 | In distribution | |
| 0102602 | In distribution | |
| 0101701 | In distribution | |
| 0103101 | In distribution | |
| 0120601 | In distribution | |
| 0103402 | In distribution | |
| 0102702 | In distribution | |
| 0102201 | In distribution | |
| 0117401 | In distribution | |
| 0945001 | In distribution | |
| 0841001 | In distribution | |
| 50004 | In distribution | |
| 0102501 | In distribution | |
| 0941201 | In distribution | |
| 0104301 | In distribution | |
| 0104201 | In distribution | |
| 0105601 | In distribution | |
| 0103901 | In distribution | |
| 0907501 | In distribution | |
| 0112201 | In distribution | |
| 0102401 | In distribution | |
| 0849201 | In distribution | |
| 0849202 | In distribution | |
| 0120301 | In distribution | |
| 0101501 | In distribution | |
| 0945701 | In distribution | |
| 0101602 | In distribution | |
| 0102301 | In distribution | |
| 0849301 | In distribution | |
| 0104401 | In distribution | |
| 0120801 | In distribution | |
| 845001 | In distribution | |
| 0104202 | In distribution | |
| 0120701 | In distribution | |
| 0906001 | In distribution | |
| 0103502 | In distribution | |
| 0841701 | In distribution | |
| 0117601 | In distribution | |
| 0906601 | In distribution | |
| 0845201 | In distribution | |
| 0104601 | In distribution | |
| 51112 | In distribution | |
| 0849101 | In distribution | |
| 0102101 | In distribution | |
| 0841801 | In distribution | |
| 0103002 | In distribution | |
| 0105301 | In distribution | |
| 0104001 | In distribution | |
| 0905001 | In distribution | |
| 0104101 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medivators Hookup | Medivators Inc | 333 |
| Connecting Tube | Olympus Medical Systems Corp. | 47 |
| Accessories, Cleaning, For Endoscope | Steris Corporation | 39 |
| Accessories, Cleaning, For Endoscope | Pentax of America, Inc. | 24 |
| Accessories, Cleaning, For Endoscope | Richard Wolf Gmbh | 16 |
| ASP Aeroflex™ | Advanced Sterilization Products Services Inc. | 10 |
| Scope Buddy Plus Tubing | Medivators Inc | 9 |
| Accessories, Cleaning, For Endoscope | Corporation Steris Canada | 8 |
| Scope Assist Flushing Sink (Safs) | Wassenburg Medical, Inc. | 6 |
| System 83 Plus | Wassenburg Medical, Inc. | 4 |
| Leak Test AIR Tube | Olympus Medical Systems Corp. | 4 |
| Sugi | Questalpha GmbH & Co. KG | 4 |
Showing 12 of 48. All products under Accessories, Cleaning, For Endoscope
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Advanced Sterilization Products | 510(k) number | 2016-09-27 | Class II | Nonconforming Material/Component | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak. | 107 units | 2017-04-17 |
| Advanced Sterilization Products | 510(k) number | 2015-05-11 | Class II | Nonconforming Material/Component | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there | 825 units | 2016-07-06 |
| Advanced Sterilization Products | 510(k) number | 2015-05-11 | Class II | Nonconforming Material/Component | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there | 44 units | 2016-07-06 |
| Advanced Sterilization Products | 510(k) number | 2013-03-28 | Class II | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Co | 761 units | 2013-08-22 |
| Advanced Sterilization Products | 510(k) number | 2013-03-22 | Class II | Nonconforming Material/Component | Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing. | 273 units | 2013-11-18 |
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.