Cleared Traditional

K180291 - Cook Silicone Balloon HSG Catheter

K180291 is the FDA 510(k) clearance for Cook Silicone Balloon HSG Catheter by Cook Incorporated. It is a Class 2 Obstetrics & Gynecology device (product code LKF) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K180291 · Cook Incorporated · Obstetrics & Gynecology device
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Oct 2018
Decision
267d
Days
Class 2
Risk

K180291 is an FDA 510(k) clearance for the Cook Silicone Balloon HSG Catheter. 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 October 26, 2018 after a review of 267 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 K180291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2018
Decision Date October 26, 2018
Days to Decision 267 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
107d slower than avg
Panel avg: 160d · This submission: 267d
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 42
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K180291.
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Intrauterine Access Balloon Catheter, Selective Salpingography Catheter
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Uterine Manipulator
K172846 · Beijing Hangtian Kadi Technology R&D Institute · Jun 2018
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
K171604 · Cook Incorporated · Feb 2018