Implantica CE Reflux , Ltd.: FDA clearances and approvals
Implantica CE Reflux , Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LEI | Implant, Anti-Gastroesophageal Reflux | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250018 | PMA | RefluxStop® Device and RefluxStop® Deployment Tool | 2026-08-20 |
Recalls
openFDA lists no recalls under a recalling firm named Implantica CE Reflux , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Implantica CE Reflux , Ltd. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05870163: Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment (Recruiting, started 2023-02-20)
Frequently asked questions
How many FDA 510(k) clearances does Implantica CE Reflux , Ltd. have?
Implantica CE Reflux , Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Implantica CE Reflux , Ltd. make?
Its most frequent FDA product codes are LEI (Implant, Anti-Gastroesophageal Reflux, 1).
Has Implantica CE Reflux , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Implantica CE Reflux , Ltd. Related entities may recall under other names.
Next steps
- See all 0 Implantica CE Reflux , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LEI, Implantica CE Reflux , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.