Cleared Traditional

K023379 - COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER

K023379 is an FDA 510(k) clearance for COOPERSURGICAL EMBRYO TRANSFER CATHETER, manufactured by Cooper Surgical. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K023379 · Cooper Surgical · Obstetrics & Gynecology device
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Dec 2002
Decision
64d
Days
Class 2
Risk

K023379 is an FDA 510(k) clearance for the COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION.... Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Cooper Surgical (Huntington, US). The FDA issued a Cleared decision on December 11, 2002 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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 Cooper Surgical devices

FDA 510(k) Submission Details - K023379

510(k) Number K023379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2002
Decision Date December 11, 2002
Days to Decision 64 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
97d faster than avg
Panel avg: 161d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQF Device Classification - Class 2, Special Controls

Product Code MQF Catheter, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
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 - MQF Catheter, Assisted Reproduction

All 51
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K023379.
TUCKER EMBRYO CATHETER
K023017 · Fertility Technology Resources, Inc. · Dec 2002
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
K023383 · Cooper Surgical · Dec 2002
COOPERSURGICAL TRIAL TRANSFER CATHETER
K023384 · Cooper Surgical · Dec 2002
IUI, MODEL 4220
K013501 · Gynetics Medical Products NV · Nov 2001
EMTRAC
K013536 · Gynetics Medical Products NV · Nov 2001
TAO EMBRYO TRANSFER CATHETER SYSTEM
K012220 · Ttj Biomedical, LLC · Aug 2001