Cleared Traditional

CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR (K946220) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946220 · Conmedcorp · Obstetrics & Gynecology device
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Sep 1995
Decision
268d
Days
Class 2
Risk

K946220 is an FDA 510(k) clearance for the CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEV.... Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 268 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.

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Submission Details

510(k) Number K946220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1994
Decision Date September 15, 1995
Days to Decision 268 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 160d · This submission: 268d
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 21
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K946220.
PROBE HOLDER SYSTEM
K071405 · Intuitive Surgical, Inc. · Oct 2007
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · Cook Urological, Inc. · Oct 2004
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
K955508 · Cook Urological, Inc. · Feb 1996
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR
K930867 · United States Surgical, A Division of Tyco Healthc · Jul 1994
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
K935434 · United States Surgical, A Division of Tyco Healthc · May 1994
BARD UTERINE MANIPULATOR
K904079 · C.R. Bard, Inc. · Feb 1991