Cleared Special

K171611 - Double Lumen Ovum Aspiration Needles (FDA 510(k) Clearance)

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

K171611 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology device
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Dec 2017
Decision
197d
Days
Class 2
Risk

K171611 is an FDA 510(k) clearance for the Double Lumen Ovum Aspiration Needles. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on December 15, 2017 after a review of 197 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all William A. Cook Australia Pty. , Ltd. devices

Submission Details

510(k) Number K171611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date December 15, 2017
Days to Decision 197 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
37d slower than avg
Panel avg: 160d · This submission: 197d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.