Cleared Traditional

K171604 - Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip

K171604 is an FDA 510(k) clearance for Rösch Thurmond Fallopian Tube Catheteri..., manufactured by Cook Incorporated. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K171604 · Cook Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K171604

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
98d slower than avg
Panel avg: 161d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKF Device Classification - Class 2, Special Controls

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 81
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
Unicare System, Unicare Manipulator
K163214 · Clearpath Surgical, Inc. · Feb 2017
uVue HSG/SHG Catheter
K160217 · Cook Incorporated · Oct 2016
Ally Uterine Positioning System
K153092 · CooperSurgical, Inc. · Dec 2015