Cameron-Miller, Inc.: FDA clearances and approvals
Cameron-Miller, Inc. has 14 FDA 510(k) clearances (first 1977, latest 1994), across 4 product codes in 4 review panels. Median 510(k) review time: 80 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 10 | 10 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 2 | 2 |
| FCT | Headlight, Fiberoptic Focusing | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
Review panels
- General and Plastic Surgery (10)
- Obstetrics and Gynecology (2)
- Gastroenterology and Urology (1)
- Ophthalmic (1)
Most recent Cameron-Miller, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944775 | ELECTROSURGICAL UNIT MODEL 26-0335 | GEI | 1994-10-11 | 14 |
| K931541 | MODEL 26-0375, ELECTROSURGICAL GENERATOR | HGI | 1994-06-01 | 429 |
| K931437 | MODEL 80-1983, ELECTROSURGICAL GENERATOR | HGI | 1994-05-27 | 431 |
| K935490 | ELECTROSURGICAL DEVICE, MODEL 26-2500 | GEI | 1994-04-01 | 137 |
| K854109 | ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345 | GEI | 1986-01-24 | 108 |
| K853972 | CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR | GEI | 1986-01-24 | 120 |
| K833449 | HAND CONTROLLED PENCIL OR SWITCH HAND | GEI | 1983-11-29 | 55 |
| K822092 | CAMERON-MILLER #40-1516 | GEI | 1982-09-21 | 67 |
| K812702 | TECHNICATOR | GEI | 1981-11-05 | 43 |
| K791415 | MODEL 80-1765 ELECTROSURGICAL UNIT | GEI | 1979-10-11 | 72 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cameron-Miller, 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 Cameron-Miller, Inc. have?
Cameron-Miller, Inc. has 14 FDA 510(k) clearances (first 1977, latest 1994), across 4 product codes in 4 review panels.
How long does FDA take to clear Cameron-Miller, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cameron-Miller, Inc.'s cleared 510(k)s is 80 days.
What devices does Cameron-Miller, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 10); HGI (Electrocautery, Gynecologic (And Accessories), 2); FCT (Headlight, Fiberoptic Focusing, 1).
Has Cameron-Miller, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cameron-Miller, Inc. Related entities may recall under other names.
Next steps
- See all 14 Cameron-Miller, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Cameron-Miller, 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.