Mainstay Medical Limited: FDA clearances and approvals
Mainstay Medical Limited 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 |
|---|---|---|---|
| QLK | Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190021 | PMA | ReActiv8 Implantable Neurostimulation System | 2020-06-16 |
Recalls
openFDA lists no recalls under a recalling firm named Mainstay Medical Limited.
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 Mainstay Medical Limited have?
Mainstay Medical Limited has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Mainstay Medical Limited make?
Its most frequent FDA product codes are QLK (Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief, 1).
Has Mainstay Medical Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Mainstay Medical Limited. Related entities may recall under other names.
Next steps
- See all 0 Mainstay Medical Limited clearances with predicates and recalls
- Run predicate analysis for product code QLK, Mainstay Medical Limited'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.