Cleared Traditional

MINISPACE(TM) IUI CATHETER

K902171 · Pharmacia, Inc. · Obstetrics & Gynecology
Oct 1990
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K902171 is an FDA 510(k) clearance for the MINISPACE(TM) IUI CATHETER, a Cap, Cervical (Class II — Special Controls, product code HDR), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on October 5, 1990, 144 days after receiving the submission on May 14, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K902171 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1990
Decision Date October 05, 1990
Days to Decision 144 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

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