Cleared Traditional

K014160 - PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC...

K014160 is the FDA 510(k) clearance for PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC... by Cook Urological, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQG) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K014160 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
51d
Days
Class 2
Risk

K014160 is an FDA 510(k) clearance for the PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES). Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Urological, Inc. devices

Submission Details

510(k) Number K014160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2001
Decision Date February 08, 2002
Days to Decision 51 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
109d faster than avg
Panel avg: 160d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 - MQG Accessory, Assisted Reproduction

All 7
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K014160.
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
K180188 · Genea Biomedx Pty, Ltd. · Jun 2018
EmbryoScope+
K173264 · Vitrolife A/S · May 2018
Geri Embryo Incubator and Geri Dish
K180304 · Genea Biomedx Pty, Ltd. · Apr 2018
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070 · Cook Urological, Inc. · Oct 1999