Cleared Traditional

GENXCATHETER (K963031) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963031 · Intl., Inc. · Obstetrics & Gynecology device
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Oct 1996
Decision
77d
Days
Class 2
Risk

K963031 is an FDA 510(k) clearance for the GENXCATHETER. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Madison, US). The FDA issued a Cleared decision on October 21, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intl., Inc. devices

Submission Details

510(k) Number K963031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date October 21, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 160d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MFD Cannula, Intrauterine Insemination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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.