Cleared Traditional

K142164 - MANIPULATOR

Also marketed or referenced as:
MANIPULATOR PRO

K142164 is an FDA 510(k) clearance for MANIPULATOR, manufactured by Gynetech Pty. , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K142164 · Gynetech Pty. , Ltd. · Obstetrics & Gynecology device
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Dec 2014
Decision
133d
Days
Class 2
Risk

K142164 is an FDA 510(k) clearance for the MANIPULATOR. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Gynetech Pty. , Ltd. (Pacifica, US). The FDA issued a Cleared decision on December 17, 2014 after a review of 133 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 Gynetech Pty. , Ltd. devices

FDA 510(k) Submission Details - K142164

510(k) Number K142164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2014
Decision Date December 17, 2014
Days to Decision 133 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 160d · This submission: 133d
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 47
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K142164.
Ally Uterine Positioning System
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Air Bubble Based Infuser (ABBI)
K143415 · CooperSurgical, Inc. · Feb 2015
VCARE
K142716 · Conmed Corporation · Feb 2015
ALLY UPS
K141523 · CooperSurgical, Inc. · Nov 2014
VCARE DX
K093556 · Conmed Corporation · Mar 2010
PROBE HOLDER SYSTEM
K071405 · Intuitive Surgical, Inc. · Oct 2007