Cleared Traditional

K982628 - MEDWORKS INSEMINATION CATHETER

K982628 is an FDA 510(k) clearance for MEDWORKS INSEMINATION CATHETER, 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 24-day FDA review.

K982628 · Medworks Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
24d
Days
Class 2
Risk

K982628 is an FDA 510(k) clearance for the MEDWORKS 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 August 21, 1998 after a review of 24 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 Medworks Corp. devices

FDA 510(k) Submission Details - K982628

510(k) Number K982628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1998
Decision Date August 21, 1998
Days to Decision 24 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
136d faster than avg
Panel avg: 160d · This submission: 24d
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 K982628.
`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