Cleared Traditional

K984306 - `THE INSEMINATOR' (PROPOSED) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984306 · Wallach Surgical Devices, Inc. · Obstetrics & Gynecology device
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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
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.