Cleared Traditional

K160217 - uVue HSG/SHG Catheter

K160217 is an FDA 510(k) clearance for uVue HSG/SHG Catheter, 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 251-day FDA review.

K160217 · Cook Incorporated · Obstetrics & Gynecology device
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Oct 2016
Decision
251d
Days
Class 2
Risk

K160217 is an FDA 510(k) clearance for the uVue HSG/SHG 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 6, 2016 after a review of 251 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 - K160217

510(k) Number K160217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2016
Decision Date October 06, 2016
Days to Decision 251 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
91d slower than avg
Panel avg: 160d · This submission: 251d
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 46
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K160217.
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
K180300 · Cook Incorporated · Oct 2018
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
Ally Uterine Positioning System
K153092 · CooperSurgical, Inc. · Dec 2015
Air Bubble Based Infuser (ABBI)
K143415 · CooperSurgical, Inc. · Feb 2015
VCARE
K142716 · Conmed Corporation · Feb 2015