510(k) K181865 ยท FEB Accessories, Cleaning, For Endoscope
Acu-sInQ Complete Endoscope Cleaning Aid System
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Dec 14, 2018 |
| Received | Jul 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181865
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2020 | Steris Corporation Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning
Part number: 0600818OKN Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.