Pinnacle Biologics, Inc.: FDA clearances and approvals
Pinnacle Biologics, Inc. has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 2 product codes in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MVF | System, Laser, Photodynamic Therapy | 1 | 0 |
| MVG | System, Laser, Fiber Optic, Photodynamic Therapy | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990021 | PMA | DIOMED 630 PDT LASER | 2000-06-30 |
| P940010 | PMA | OPTIGUIDE(TM) FIBER OPTIC DIFFUSER | 1995-12-27 |
Recalls
openFDA lists no recalls under a recalling firm named Pinnacle Biologics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pinnacle Biologics, Inc. have?
Pinnacle Biologics, Inc. has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 2 product codes in 1 review panel.
What devices does Pinnacle Biologics, Inc. make?
Its most frequent FDA product codes are MVF (System, Laser, Photodynamic Therapy, 1); MVG (System, Laser, Fiber Optic, Photodynamic Therapy, 1).
Has Pinnacle Biologics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pinnacle Biologics, Inc. Related entities may recall under other names.
Next steps
- See all 0 Pinnacle Biologics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MVF, Pinnacle Biologics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.