Cleared Special

K140761 - KAHN UTERINE CANNULA

K140761 is an FDA 510(k) clearance for KAHN UTERINE CANNULA, manufactured by Carefusion 2200, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HES cleared through the Special 510(k) pathway after a 26-day FDA review.

K140761 · Carefusion 2200, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K140761

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.

HES Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HES Insufflator, Carbon-dioxide, Uterotubal (and Accessories)

Devices cleared under the same product code (HES) and FDA review panel - the closest regulatory comparables to K140761.
CORE DISPOSABLE INSUFFLATION TUBING
K901413 · Core Dynamics, Inc. · Sep 1990
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
K891290 · Cook Ob/Gyn · May 1989
BARD HYSTEROSALPINGOGRAPHY CATHETERS
K890869 · C.R. Bard, Inc. · Apr 1989
UTERINE INJECTOR 2MM
K873515 · Zinnanti Surgical Instruments, Inc. · Sep 1987
CABOT MEDICAL VARIABLE FLOW INSUFFLATOR
K862310 · Cabot Medical Corp. · Aug 1986