Cleared Traditional

WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM (K964848) - FDA 510(k) Clearance

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

K964848 · Marlow Surgical Technologies, Inc. · Obstetrics & Gynecology device
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Jan 1997
Decision
44d
Days
Class 2
Risk

K964848 is an FDA 510(k) clearance for the WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Marlow Surgical Technologies, Inc. (Willoughby, US). The FDA issued a Cleared decision on January 16, 1997 after a review of 44 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 Marlow Surgical Technologies, Inc. devices

Submission Details

510(k) Number K964848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date January 16, 1997
Days to Decision 44 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
116d faster than avg
Panel avg: 160d · This submission: 44d
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.