Cleared Traditional

K982630 - MEDWORKS VISUALIZATION INSEMINATION CAT...

K982630 is an FDA 510(k) clearance for MEDWORKS VISUALIZATION INSEMINATION CAT..., manufactured by Medworks Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K982630 · Medworks Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 1999
Decision
170d
Days
Class 2
Risk

K982630 is an FDA 510(k) clearance for the MEDWORKS VISUALIZATION INSEMINATION CATHETER. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Medworks Corp. (Pawtucket, US). The FDA issued a Cleared decision on January 14, 1999 after a review of 170 days - an extended review 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: 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 Medworks Corp. devices

FDA 510(k) Submission Details - K982630

510(k) Number K982630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1998
Decision Date January 14, 1999
Days to Decision 170 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
10d slower than avg
Panel avg: 160d · This submission: 170d
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 12
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K982630.
`THE INSEMINATOR' (PROPOSED)
K984306 · Wallach Surgical Devices, Inc. · Mar 1999
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