CooperSurgical, Inc.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “CooperSurgical, Inc.” (first 1991, latest 2026), plus 3 PMA decisions, across 23 product codes in 5 review panels. Median 510(k) review time under this name: 110 days. Since 2017 the median was 63 days, against 163 days for all cleared 510(k)s in the same product codes. 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 | 2 | 190 |
| 2015 | 3 | 90 |
| 2016 | 1 | 255 |
| 2017 | 2 | 84 |
| 2018 | 2 | 56 |
| 2019 | 4 | 77 |
| 2020 | 3 | 28 |
| 2021 | 0 | — |
| 2022 | 1 | 28 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 158 |
| 2026 | 1 | 140 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CooperSurgical, Inc. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 163 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | 5 | 5 |
| HEW | Culdoscope (And Accessories) | 4 | 4 |
| LKF | Cannula, Manipulator/Injector, Uterine | 4 | 4 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 | 3 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 3 |
| MQE | Needle, Assisted Reproduction | 3 | 3 |
| MQF | Catheter, Assisted Reproduction | 3 | 3 |
| HEE | Set, Anesthesia, Paracervical | 2 | 2 |
| HEX | Colposcope (And Colpomicroscope) | 2 | 2 |
| MNB | Device, Thermal Ablation, Endometrial | 2 | 0 |
Plus 13 more product codes.
Review panels
- Obstetrics and Gynecology (39)
- Gastroenterology and Urology (3)
- General Hospital (1)
- Physical Medicine (1)
- Radiology (1)
Most recent CooperSurgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) | MQG | 2026-08-19 | 140 |
| K243799 | Fetal Pillow | PWB | 2025-08-29 | 261 |
| K250438 | CooperSurgical Milex® Pessaries | HHW | 2025-04-11 | 56 |
| K223064 | ALLY II Uterine Positioning System (UPS) | LKF | 2022-10-28 | 28 |
| K201086 | Advincula Delineator Uterine Manipulator | HEW | 2020-05-21 | 28 |
| K200038 | Endosee System | HIH | 2020-02-05 | 28 |
| K191020 | G210 InviCell Plus with SignipHy pH monitoring | PUB | 2020-01-14 | 272 |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | MQE | 2019-06-12 | 29 |
| K190639 | Endosee System | HIH | 2019-05-15 | 63 |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | MQE | 2019-05-10 | 197 |
32 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160047 | PMA | MARA Vapor System, MARA Vapor Probe Procedure Kit, MARA Vapor Generator and MARA Vapor Generator Accessory Kit | 2017-06-14 |
| P000032 | PMA | HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM | 2001-04-20 |
| P990016 | PMA | MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 | 2000-01-07 |
Recalls
87 product recalls in 59 recall events; 28 initiated in the last five years. Most recent: 2026-08-11.
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.
Device clinical trials
An industry sponsor named CooperSurgical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05309694: A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive) (Completed, started 2022-03-04)
- NCT00094536: Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System (Completed, started 2004-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under CooperSurgical, Inc.?
FDA lists 42 510(k) clearances under the applicant name “CooperSurgical, Inc.” (first 1991, latest 2026), plus 3 PMA decisions, across 23 product codes in 5 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 CooperSurgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name CooperSurgical, Inc. is 110 days. Since 2017: 63 days, versus 163 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CooperSurgical, Inc.?
The most frequent FDA product codes under this applicant name are HIH (Hysteroscope (And Accessories), 5); HEW (Culdoscope (And Accessories), 4); LKF (Cannula, Manipulator/Injector, Uterine, 4).
Next steps
- See all 42 CooperSurgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIH, CooperSurgical, 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.