Cleared Traditional

K984306 - `THE INSEMINATOR' (PROPOSED)

K984306 is the FDA 510(k) clearance for `THE INSEMINATOR' (PROPOSED) by Wallach Surgical Devices, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MFD) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K984306 · Wallach Surgical Devices, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
89d
Days
Class 2
Risk

K984306 is an FDA 510(k) clearance for the `THE INSEMINATOR' (PROPOSED). Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wallach Surgical Devices, Inc. devices

Submission Details

510(k) Number K984306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1998
Decision Date March 01, 1999
Days to Decision 89 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
71d faster than avg
Panel avg: 160d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K984306.
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 II
K954398 · Cook Urological, Inc. · Dec 1995
INSEMI-CATH
K931630 · Cook Ob/Gyn · Apr 1994
MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE
K923612 · Life-Tech Intl., Inc. · Sep 1993