Cleared Traditional

K041062 - INTRAUTERINE VENOGRAM NEEDLE SET

K041062 is the FDA 510(k) clearance for INTRAUTERINE VENOGRAM NEEDLE SET by Cook Urological, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code LKF) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K041062 · Cook Urological, Inc. · Obstetrics & Gynecology device
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Oct 2004
Decision
161d
Days
Class 2
Risk

K041062 is an FDA 510(k) clearance for the INTRAUTERINE VENOGRAM NEEDLE SET. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on October 1, 2004 after a review of 161 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 Urological, Inc. devices

Submission Details

510(k) Number K041062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2004
Decision Date October 01, 2004
Days to Decision 161 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
1d slower than avg
Panel avg: 160d · This submission: 161d
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 29
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K041062.
VCARE DX
K093556 · Conmed Corporation · Mar 2010
PROBE HOLDER SYSTEM
K071405 · Intuitive Surgical, Inc. · Oct 2007
VCARE RETRACTOR/ELEVATOR
K071907 · Conmed Corporation · Oct 2007
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
K000433 · Medical Device Technologies, Inc. · Jun 2000
CONMED VCARE RETRACTOR/ELEVATOR
K955446 · Conmedcorp · Jun 1996
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
K955508 · Cook Urological, Inc. · Feb 1996