Cleared Traditional

K943494 - HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY

K943494 is an FDA 510(k) clearance for HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY, manufactured by Lyco Enterprises, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K943494 · Lyco Enterprises, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
352d
Days
Class 2
Risk

K943494 is an FDA 510(k) clearance for the HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Lyco Enterprises, Inc. (El Paso, US). The FDA issued a Cleared decision on July 6, 1995 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Lyco Enterprises, Inc. devices

FDA 510(k) Submission Details - K943494

510(k) Number K943494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date July 06, 1995
Days to Decision 352 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
192d slower than avg
Panel avg: 160d · This submission: 352d
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 61
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K943494.
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
K955508 · Cook Urological, Inc. · Feb 1996
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR
K946220 · Conmedcorp · Sep 1995
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K953034 · Ackrad Laboratories · Aug 1995
LUMIN
K943448 · Utah Medical Products, Inc. · Apr 1995
UTERINE MANIPULATOR/INJECTOR WITH SPRING
K941458 · Zinnanti Surgical Instruments, Inc. · Jan 1995
UTERINE INJECTOR WITH SPRING
K941457 · Zinnanti Surgical Instruments, Inc. · Jan 1995