Cirtec Medical Corporation: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Cirtec Medical Corporation”, 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 |
|---|---|---|---|
| EZW | Stimulator, Electrical, Implantable, For Incontinence | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170001 | PMA | VIRTIS SACRAL NEUROMODULATION SYSTEM | 2023-01-11 |
Recalls
openFDA lists no recalls under a recalling firm named Cirtec Medical Corporation.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cirtec Medical Corporation (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via EZW)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cirtec Medical Corporation?
FDA lists 0 510(k) clearances under the applicant name “Cirtec Medical Corporation”, 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 Cirtec Medical Corporation?
The most frequent FDA product codes under this applicant name are EZW (Stimulator, Electrical, Implantable, For Incontinence, 1).
Next steps
- See all 0 Cirtec Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code EZW, Cirtec Medical Corporation'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.