Microsulis Medical , Ltd.: FDA clearances and approvals
Microsulis Medical , Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNB | Device, Thermal Ablation, Endometrial | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P020031 | PMA | MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM | 2003-09-23 |
Recalls
openFDA lists no recalls under a recalling firm named Microsulis Medical , 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.
Frequently asked questions
How many FDA 510(k) clearances does Microsulis Medical , Ltd. have?
Microsulis Medical , Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Microsulis Medical , Ltd. make?
Its most frequent FDA product codes are MNB (Device, Thermal Ablation, Endometrial, 1).
Has Microsulis Medical , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Microsulis Medical , Ltd. Related entities may recall under other names.
Next steps
- See all 0 Microsulis Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MNB, Microsulis Medical , 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.