Cleared Traditional

INSEMI-CATH

K931630 · Cook Ob/Gyn · Obstetrics & Gynecology
Apr 1994
Decision
382d
Days
Class 2
Risk

About This 510(k) Submission

K931630 is an FDA 510(k) clearance for the INSEMI-CATH, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on April 19, 1994, 382 days after receiving the submission on April 2, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K931630 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1993
Decision Date April 19, 1994
Days to Decision 382 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MFD — Cannula, Intrauterine Insemination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5250

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