Microcube, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Microcube, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| P230002 | PMA | Minitouch 3.8 Era System (Minitouch System) | 2023-07-28 |
Recalls
openFDA lists no recalls under a recalling firm named Microcube, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Microcube, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04267562: Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (Completed, started 2020-02-28)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microcube, LLC?
FDA lists 0 510(k) clearances under the applicant name “Microcube, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Microcube, LLC?
The most frequent FDA product codes under this applicant name are MNB (Device, Thermal Ablation, Endometrial, 1).
Next steps
- See all 0 Microcube, LLC clearances with predicates and recalls
- Run predicate analysis for product code MNB, Microcube, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.