Cleared Traditional

K142716 - VCARE

K142716 is the FDA 510(k) clearance for VCARE by Conmed Corporation. It is a Class 2 Obstetrics & Gynecology device (product code LKF) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K142716 · Conmed Corporation · Obstetrics & Gynecology device
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Feb 2015
Decision
140d
Days
Class 2
Risk

K142716 is an FDA 510(k) clearance for the VCARE. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on February 10, 2015 after a review of 140 days - within the typical 510(k) review window.

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 Conmed Corporation devices

Submission Details

510(k) Number K142716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2014
Decision Date February 10, 2015
Days to Decision 140 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
20d faster than avg
Panel avg: 160d · This submission: 140d
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 28
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K142716.
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
uVue HSG/SHG Catheter
K160217 · Cook Incorporated · Oct 2016
VCARE DX
K093556 · Conmed Corporation · Mar 2010
PROBE HOLDER SYSTEM
K071405 · Intuitive Surgical, Inc. · Oct 2007
VCARE RETRACTOR/ELEVATOR
K071907 · Conmed Corporation · Oct 2007