Starr Surgical Co.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Starr Surgical Co.”, plus 2 PMA decisions, across 2 product codes 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 |
|---|---|---|---|
| HQL | Intraocular Lens | 1 | 0 |
| OGO | Intraocular Pressure Lowering Implant | 1 | 0 |
Review panels
- Ophthalmic (2)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000026 | PMA | STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20 | 2001-07-12 |
| P990013 | PMA | COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | 2000-04-02 |
Recalls
openFDA lists no recalls under a recalling firm named Starr Surgical Co..
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.
- Starr Frame, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Starr Surgical Co.?
FDA lists 0 510(k) clearances under the applicant name “Starr Surgical Co.”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Starr Surgical Co.?
The most frequent FDA product codes under this applicant name are HQL (Intraocular Lens, 1); OGO (Intraocular Pressure Lowering Implant, 1).
Next steps
- See all 0 Starr Surgical Co. clearances with predicates and recalls
- Run predicate analysis for product code HQL, Starr Surgical Co.'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.