Cleared Traditional

OVAMED FALLOPIAN OSTIAL ACCESS CATHETER

K931167 · Ovamed Corp. · Obstetrics & Gynecology
Jun 1995
Decision
836d
Days
Class 2
Risk

About This 510(k) Submission

K931167 is an FDA 510(k) clearance for the OVAMED FALLOPIAN OSTIAL ACCESS 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 June 22, 1995, 836 days after receiving the submission on March 8, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K931167 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1993
Decision Date June 22, 1995
Days to Decision 836 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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