Cleared Traditional

K151018 - Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette

K151018 is an FDA 510(k) clearance for Embryo Biopsy Pipette, manufactured by Cook Incorporated. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K151018 · Cook Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
267d
Days
Class 2
Risk

K151018 is an FDA 510(k) clearance for the Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction.... Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on January 8, 2016 after a review of 267 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6130 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151018

510(k) Number K151018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2015
Decision Date January 08, 2016
Days to Decision 267 days
Submission Type Traditional
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
106d slower than avg
Panel avg: 161d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQH Device Classification - Class 2, Special Controls

Product Code MQH Microtools, Assisted Reproduction (pipettes)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6130
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 - MQH Microtools, Assisted Reproduction (pipettes)

All 25
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K151018.
V-DENUPET
K192146 · Vitromed GmbH · Jan 2020
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
K161275 · Research Instruments Limited · Jan 2017
LifeGlobal Micro Tips
K152581 · Life Global Group, LLC · Apr 2016
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748 · Cook Incorporated · Dec 2015
BIOPSY PIPETTES
K133257 · Research Instruments , Ltd. · May 2014
INJECTION PIPETTE
K102480 · Jieying Laboratory, Inc. · Apr 2011
K151018 · Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
Download PDF FDA Summary Cook Incorporated