Cleared Special

FEMVUE CORNUAL BALLOON CATHETER

K100662 · Femasys, Inc. · Obstetrics & Gynecology
Apr 2010
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K100662 is an FDA 510(k) clearance for the FEMVUE CORNUAL BALLOON CATHETER, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Femasys, Inc. (Suwanee, US). The FDA issued a Cleared decision on April 7, 2010, 30 days after receiving the submission on March 8, 2010. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K100662 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2010
Decision Date April 07, 2010
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

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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