Medical Device Manufacturer · US , Huntington , CT

Cooper Surgical

6 submissions · 6 cleared · Since 2002

Total

Cleared

Denied

Cooper Surgical — FDA 510(k) Submissions

Cooper Surgical has submitted 6 FDA 510(k) premarket notifications since 2002, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Assisted Reproduction, Densitometer, Bone, Pessary, Vaginal . Use the specialty filter in the sidebar to narrow results.

6 devices

1–6 of 6

Milex? Incontinence Dish Pessaries; Milex? Incontinence Dish Pessaries with Support; Milex? Cube Pessaries; Milex? Cube Pessaries with Drainage Holes

K253698 · HHW Pessary, Vaginal · Obstetrics & Gynecology

Jan 2026 57d

TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS

K091325 · KGI Densitometer, Bone · Radiology

Jun 2009 55d

COOPERSURGICAL MALLEABLE SYTLET

K023382 · MQF Catheter, Assisted... · Obstetrics & Gynecology

Dec 2002 73d

COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER