510(k) K183072 ยท FFX System, Gastrointestinal Motility (Electrical)
EndoFLIP System
| Applicant | Crospon, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Feb 15, 2019 |
| Received | Nov 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Covidien, LLC EndoFLIP System that includes:
ENDOFLIP 1 SYSTEM EF-100
05391530810050
10884521809307
REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1
10884521808096
05391530810166
DL ENDOFLIP 1
10884521786684 Open, Classified |
FFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.