Cleared Special

K140761 - KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (FDA 510(k) Clearance)

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

K140761 · Carefusion 2200, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 2014
Decision
26d
Days
Class 2
Risk

K140761 is an FDA 510(k) clearance for the KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA. Classified as Insufflator, Carbon-dioxide, Uterotubal (and Accessories) (product code HES), Class II - Special Controls.

Submitted by Carefusion 2200, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on April 21, 2014 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1300 - 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 Carefusion 2200, Inc. devices

Submission Details

510(k) Number K140761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2014
Decision Date April 21, 2014
Days to Decision 26 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
134d faster than avg
Panel avg: 160d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HES Insufflator, Carbon-dioxide, Uterotubal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1300
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.