510(k) K040883 ยท FEB Accessories, Cleaning, For Endoscope
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Mar 15, 2005 |
| Received | Apr 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2017 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004
The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant C Terminated |
FEB | None listed |
| Aug 8, 2008 | Advanced Sterilization Products EvoTech Endoscope Cleaner & Reprocessor, Product
Code 50004
Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high Terminated |
FEB | None listed |
| Aug 8, 2008 | Advanced Sterilization Products EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002
Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.