FDA applicant

Coopervision Surgical

Trumbull3 decisions1975–19921 recall

FDA records 3 decisions for Coopervision Surgical (Trumbull) from 1975 to 1992: 2 510(k) clearances and 1 original PMA approval. Most are in product codes LTA (Fluid, Hysteroscopy) and GCT (Light Source, Endoscope, Xenon Arc). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Coopervision Surgical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coopervision Surgical since 2007.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Coopervision Surgical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coopervision Surgical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Coopervision”

FDA records each applicant name separately; these may or may not be the same firm.

CooperVision, Inc. 106 Coopervision-Cilco 3

Coopervision Surgical

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Coopervision”