Focus Surgery, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Focus Surgery, Inc.”, 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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890066 | PMA | THERASONIC LITHOTRIPSY TREATMENT SYSTEM | 1991-12-20 |
Recalls
openFDA lists no recalls under a recalling firm named Focus Surgery, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Focus Diagnostics, Inc. (16 510(k)s)
- Focus Medical, LLC (9 510(k)s)
- Focus Technologies, Inc. (5 510(k)s)
- Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC (1 510(k)s)
- Focus International, Inc. (1 510(k)s)
- Focus Medical SA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Focus Surgery, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Focus Surgery, Inc.”, 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 Focus Surgery, Inc.?
The most frequent FDA product codes under this applicant name are LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 1).
Next steps
- See all 0 Focus Surgery, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNS, Focus Surgery, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.