Cleared Traditional

K150748 - Flexipet Denuding Pipette

K150748 is the FDA 510(k) clearance for Flexipet Denuding Pipette by Cook Incorporated. It is a Class 2 Obstetrics & Gynecology device (product code MQH) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K150748 · Cook Incorporated · Obstetrics & Gynecology device
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Dec 2015
Decision
270d
Days
Class 2
Risk

K150748 is an FDA 510(k) clearance for the Flexipet Denuding Pipette, Flexipet Manipulation Pipette. 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 December 18, 2015 after a review of 270 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.

View all Cook Incorporated devices

Submission Details

510(k) Number K150748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2015
Decision Date December 18, 2015
Days to Decision 270 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
110d slower than avg
Panel avg: 160d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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)

Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K150748.
Denudation Pipettes
K250838 · Guangzhou Pinzhi Medical Device Co., Ltd. · Jul 2025
V-DENUPET
K192146 · Vitromed GmbH · Jan 2020
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
K151018 · Cook Incorporated · Jan 2016
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
K033903 · Cook Urological, Inc. · Jan 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · Cook Urological, Inc. · Jan 2004