Cleared Special

K100662 - FEMVUE CORNUAL BALLOON CATHETER (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K100662 is an FDA 510(k) clearance for the FEMVUE CORNUAL BALLOON CATHETER. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Femasys, Inc. (Suwanee, US). The FDA issued a Cleared decision on April 7, 2010 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Femasys, Inc. devices

Submission Details

510(k) Number K100662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - LKF Cannula, Manipulator/injector, Uterine

All 86
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K100662.
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