Cleared Traditional

OVAMED HSG CATHETER

K931122 · Ovamed Corp. · Obstetrics & Gynecology
Jan 1995
Decision
697d
Days
Class 2
Risk

About This 510(k) Submission

K931122 is an FDA 510(k) clearance for the OVAMED HSG CATHETER, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Ovamed Corp. (Sunnyvale, US). The FDA issued a Cleared decision on January 30, 1995, 697 days after receiving the submission on March 4, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K931122 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1993
Decision Date January 30, 1995
Days to Decision 697 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code LKF — Cannula, Manipulator/injector, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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