Cleared Traditional

MEDWORKS VISUALIZATION INSEMINATION CATHETER

K982630 · Medworks Corp. · Obstetrics & Gynecology
Jan 1999
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K982630 is an FDA 510(k) clearance for the MEDWORKS VISUALIZATION INSEMINATION CATHETER, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Medworks Corp. (Pawtucket, US). The FDA issued a Cleared decision on January 14, 1999, 170 days after receiving the submission on July 28, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K982630 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1998
Decision Date January 14, 1999
Days to Decision 170 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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