Cleared Traditional

K093556 - VCARE DX

K093556 is an FDA 510(k) clearance for VCARE DX, manufactured by Conmed Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K093556 · Conmed Corporation · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
115d
Days
Class 2
Risk

K093556 is an FDA 510(k) clearance for the VCARE DX. 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 March 12, 2010 after a review of 115 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.

FDA 510(k) Submission Details - K093556

510(k) Number K093556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2009
Decision Date March 12, 2010
Days to Decision 115 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
46d faster than avg
Panel avg: 161d · This submission: 115d
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 86
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K093556.
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
K092969 · Sterling Medical, Inc. · Apr 2010
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
K092984 · Panpac Medical Corporation · Apr 2010
FEMVUE CORNUAL BALLOON CATHETER
K100662 · Femasys, Inc. · Apr 2010
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
K092980 · Panpac Medical Corporation · Mar 2010
EZ HSG CATHETER.FOAMSEAL CATHETER
K083594 · Obg Products · Jul 2009
FEMVUE(TM) CATHETER SYSTEM
K083690 · Femasys, Inc. · Jun 2009
K093556 · VCARE DX
Download PDF FDA Summary Conmed Corporation