Cleared Traditional

K023017 - TUCKER EMBRYO CATHETER

K023017 is an FDA 510(k) clearance for TUCKER EMBRYO CATHETER, manufactured by Fertility Technology Resources, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K023017 · Fertility Technology Resources, Inc. · Obstetrics & Gynecology device
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Dec 2002
Decision
94d
Days
Class 2
Risk

K023017 is an FDA 510(k) clearance for the TUCKER EMBRYO CATHETER. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Fertility Technology Resources, Inc. (Marietta, US). The FDA issued a Cleared decision on December 13, 2002 after a review of 94 days - within the typical 510(k) review window.

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: 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 - K023017

510(k) Number K023017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2002
Decision Date December 13, 2002
Days to Decision 94 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 161d · This submission: 94d
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 52
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K023017.
MORTON IUI CATHETERS
K041470 · Fertility Technology Resources, Inc. · Nov 2004
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
K033084 · Portex , Ltd. · Dec 2003
COOPERSURGICAL MALLEABLE SYTLET
K023382 · Cooper Surgical · Dec 2002
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
K023383 · Cooper Surgical · Dec 2002
COOPERSURGICAL TRIAL TRANSFER CATHETER
K023384 · Cooper Surgical · Dec 2002
COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
K023379 · Cooper Surgical · Dec 2002
K023017 · TUCKER EMBRYO CATHETER
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