Cooper Medical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cooper Medical Corp.” (first 1982, latest 1984), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 172 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 |
|---|---|---|---|
| FCG | Biopsy Needle | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| LLF | Laser, Neurosurgical, Argon | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Cooper Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840144 | YAG LASER 8000 GASTROINTESTINAL BLEE | FCG | 1984-05-18 | 126 |
| K833387 | ARGON LASER SURGICAL SYSTEM 770 | — | 1984-04-18 | 202 |
| K833497 | COOPER MEDICAL MODEL 770 | LLF | 1984-04-17 | 189 |
| K832703 | ARGON LASER SYS-MODEL 5000 | HQE | 1984-01-30 | 172 |
| K820261 | MONITOR CO2 LASER SYSTEM | HHR | 1982-03-05 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Cooper Medical Corp..
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.
- Cooper Lasersonics, Inc. (54 510(k)s)
- Cooper Biomedical, Inc. (19 510(k)s)
- Cooper Medical Devices Corp. (7 510(k)s)
- Cooper Surgical (6 510(k)s)
- Cooper Diagnostics, Inc. (1 510(k)s)
- Cooper Laboratories (1 510(k)s)
- Cooper Surgical/Aesthete (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cooper Medical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Cooper Medical Corp.” (first 1982, latest 1984), across 5 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 Cooper Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cooper Medical Corp. is 172 days.
Which FDA product codes appear under Cooper Medical Corp.?
The most frequent FDA product codes under this applicant name are FCG (Biopsy Needle, 1); HHR (Laser, Surgical, Gynecologic, 1); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 1).
Next steps
- See all 5 Cooper Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FCG, Cooper Medical Corp.'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.