Cleared Special

K141365 - OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN

K141365 is an FDA 510(k) clearance for OTRIEVA TAPERED OVUM ASPIRATION NEEDLE ..., manufactured by William A. Cook Australia Pty. , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Special 510(k) pathway after a 76-day FDA review.

K141365 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
76d
Days
Class 2
Risk

K141365 is an FDA 510(k) clearance for the OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, Queensland, AU). The FDA issued a Cleared decision on August 7, 2014 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - 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.

FDA 510(k) Submission Details - K141365

510(k) Number K141365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2014
Decision Date August 07, 2014
Days to Decision 76 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 161d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
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 - MQE Needle, Assisted Reproduction

All 32
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K141365.
Follicle Aspiration Set, Reduced Single Lumen
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KITAZATO OPU NEEDLE
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K051742 · Inntec, Inc. · Oct 2005