Cooper Surgical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cooper Surgical” (first 2002, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 65 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CooperCompanies, based on public ownership records.
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 | 1 | 57 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cooper Surgical took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 212 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQF | Catheter, Assisted Reproduction | 4 | 4 |
| HHW | Pessary, Vaginal | 1 | 1 |
| KGI | Densitometer, Bone | 1 | 1 |
Review panels
Most recent Cooper Surgical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes | HHW | 2026-01-20 | 57 |
| K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS | KGI | 2009-06-29 | 55 |
| K023382 | COOPERSURGICAL MALLEABLE SYTLET | MQF | 2002-12-20 | 73 |
| K023384 | COOPERSURGICAL TRIAL TRANSFER CATHETER | MQF | 2002-12-13 | 66 |
| K023383 | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER | MQF | 2002-12-13 | 66 |
| K023379 | COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER | MQF | 2002-12-11 | 64 |
Recalls
30 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2013-02-26.
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-Hewitt Electric Co. (8 510(k)s)
- Cooper Medical Devices Corp. (7 510(k)s)
- Cooper Medical Corp. (5 510(k)s)
- Cooper Diagnostics, Inc. (1 510(k)s)
- Cooper Laboratories (1 510(k)s)
- Cooper Surgical/Aesthete (1 510(k)s)
- The Cooper Companies (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cooper Surgical?
FDA lists 6 510(k) clearances under the applicant name “Cooper Surgical” (first 2002, latest 2026), across 3 product codes in 2 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 Surgical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cooper Surgical is 65 days.
Which FDA product codes appear under Cooper Surgical?
The most frequent FDA product codes under this applicant name are MQF (Catheter, Assisted Reproduction, 4); HHW (Pessary, Vaginal, 1); KGI (Densitometer, Bone, 1).
Next steps
- See all 6 Cooper Surgical clearances with predicates and recalls
- Run predicate analysis for product code MQF, Cooper Surgical'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.