Cleared Traditional

COOK INSEMINATION CUP

K950714 · Cook Urological, Inc. · Obstetrics & Gynecology
May 1995
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K950714 is an FDA 510(k) clearance for the COOK INSEMINATION CUP, a Cap, Cervical (Class II — Special Controls, product code HDR), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on May 11, 1995, 85 days after receiving the submission on February 15, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K950714 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1995
Decision Date May 11, 1995
Days to Decision 85 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HDR — Cap, Cervical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5250