Coopervision Surgical: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Coopervision Surgical” (first 1991, latest 1992), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 196 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 |
|---|---|---|---|
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
| LTA | Fluid, Hysteroscopy | 1 | 0 |
Review panels
Most recent Coopervision Surgical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921390 | XENON LIGHT SOURCE AND ACCESSORIES | GCT | 1992-07-27 | 126 |
| K905747 | LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR | HGI | 1991-09-17 | 267 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N17511 | PMA | HYSKON (32% DEXTRAN 70) | 1975-09-15 |
Recalls
openFDA lists no recalls under a recalling firm named Coopervision Surgical.
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.
- CooperVision, Inc. (97 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coopervision Surgical?
FDA lists 2 510(k) clearances under the applicant name “Coopervision Surgical” (first 1991, latest 1992), plus 1 PMA decision, 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 Coopervision Surgical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coopervision Surgical is 196 days.
Which FDA product codes appear under Coopervision Surgical?
The most frequent FDA product codes under this applicant name are GCT (Light Source, Endoscope, Xenon Arc, 1); HGI (Electrocautery, Gynecologic (And Accessories), 1); LTA (Fluid, Hysteroscopy, 1).
Next steps
- See all 2 Coopervision Surgical clearances with predicates and recalls
- Run predicate analysis for product code GCT, Coopervision 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, 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.