Cameron-Miller, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Cameron-Miller, Inc.” (first 1977, latest 1994), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 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 Cameron-Miller, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Cameron-Miller, Inc.” (first 1977, latest 1994), across 4 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cameron-Miller, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cameron-Miller, Inc. is 80 days.
Which FDA product codes appear under Cameron-Miller, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 10); HGI (Electrocautery, Gynecologic (And Accessories), 2); FCT (Headlight, Fiberoptic Focusing, 1).
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. 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.