Cleared Traditional

EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER

K980061 · Rocket Medical Plc · Obstetrics & Gynecology
Mar 1998
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K980061 is an FDA 510(k) clearance for the EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Rocket Medical Plc (Stamford, US). The FDA issued a Cleared decision on March 2, 1998, 54 days after receiving the submission on January 7, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K980061 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1998
Decision Date March 02, 1998
Days to Decision 54 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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