Galen Robotics: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Galen Robotics”, plus 1 De Novo 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 |
|---|---|---|---|
| QXG | Cooperative Powered Surgical Assist Device For Ent Surgery | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220047 | De Novo | Cooperative Powered Surgical Assist Device For Ent Surgery | 2023-07-19 |
Recalls
openFDA lists no recalls under a recalling firm named Galen Robotics.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Galen Robotics?
FDA lists 0 510(k) clearances under the applicant name “Galen Robotics”, plus 1 De Novo 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 Galen Robotics?
The most frequent FDA product codes under this applicant name are QXG (Cooperative Powered Surgical Assist Device For Ent Surgery, 1).
Next steps
- See all 0 Galen Robotics clearances with predicates and recalls
- Run predicate analysis for product code QXG, Galen Robotics'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.