Cleared Traditional

Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip (K171604) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171604 · Cook Incorporated · Obstetrics & Gynecology device
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Feb 2018
Decision
259d
Days
Class 2
Risk

K171604 is an FDA 510(k) clearance for the Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheteriza.... Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 15, 2018 after a review of 259 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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 K171604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date February 15, 2018
Days to Decision 259 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
99d slower than avg
Panel avg: 160d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - LKF Cannula, Manipulator/injector, Uterine

All 20
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K171604.
Cook Silicone Balloon HSG Catheter
K180291 · Cook Incorporated · Oct 2018
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
K180300 · Cook Incorporated · Oct 2018
Uterine Manipulator
K172846 · Beijing Hangtian Kadi Technology R&D Institute · Jun 2018
uVue HSG/SHG Catheter
K160217 · Cook Incorporated · Oct 2016
PROBE HOLDER SYSTEM
K071405 · Intuitive Surgical, Inc. · Oct 2007
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · Cook Urological, Inc. · Oct 2004