Cleared Traditional

IMAGYN INTRAUTERINE INSEMINATION DEVICE

K945131 · Imagyn Medical, Inc. · Obstetrics & Gynecology
May 1995
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K945131 is an FDA 510(k) clearance for the IMAGYN INTRAUTERINE INSEMINATION DEVICE, a Cap, Cervical (Class II — Special Controls, product code HDR), submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on May 15, 1995, 208 days after receiving the submission on October 19, 1994. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K945131 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1994
Decision Date May 15, 1995
Days to Decision 208 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