Cleared Traditional

K954398 - INSEMI-CATH II

K954398 is an FDA 510(k) clearance for INSEMI-CATH II, manufactured by Cook Urological, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K954398 · Cook Urological, Inc. · Obstetrics & Gynecology device
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Dec 1995
Decision
90d
Days
Class 2
Risk

K954398 is an FDA 510(k) clearance for the INSEMI-CATH II. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on December 19, 1995 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - 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

FDA 510(k) Submission Details - K954398

510(k) Number K954398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1995
Decision Date December 19, 1995
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MFD Device Classification - Class 2, Special Controls

Product Code MFD Cannula, Intrauterine Insemination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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 - MFD Cannula, Intrauterine Insemination

All 19
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K954398.
GENXCATHETER
K963031 · Intl., Inc. · Oct 1996
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
K962273 · Marlo Surgical Technology · Jul 1996
ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
K940176 · Ackrad Laboratories · Apr 1996
INSEMI-CATH
K931630 · Cook Ob/Gyn · Apr 1994
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
K914541 · Irvine Scientific · Feb 1994
MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE
K923612 · Life-Tech Intl., Inc. · Sep 1993