Medworks Insemination Catheter

FDA 510(k) K982628 · Medworks Corp.

Substantially Equivalent

510(k) numberK982628

Submission

Device name
Medworks Insemination Catheter
Applicant
Medworks Corp.
Pawtucket, RI, US
Received
July 28, 1998
Decision date
August 21, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MFD – Cannula, Intrauterine Insemination
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5250
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code MFD

510(k)DeviceApplicantDecision
K021438Insemination Catheter, Model 320301MFD · Abbreviated Labotect Labor-Technik Gottingen07/16/2002SE
K012935Thecurve, Item 507MFD · Traditional Select Medical Systems, Inc.10/11/2001SE
K984306`The Inseminator' (Proposed)MFD · Traditional Wallach Surgical Devices, Inc.03/01/1999SE
K982630Medworks Visualization Insemination CatheterMFD · Traditional Medworks Corp.01/14/1999SE
K980061Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination…MFD · Traditional Rocket Medical Plc03/02/1998SE
K972823Mini-Embryon Intra Uterine Insemination CatheterMFD · Traditional A & A Medical, Inc.10/10/1997SE
K972245Tom Cat F.L., Tom Cat S.L.MFD · Traditional A & A Medical, Inc.08/06/1997SE
K970750Microspan Insemination SystemMFD · Traditional Imagyn Medical, Inc.05/05/1997SE
K964848Wallace Artificial Insemination Catheter - 8CM/18CMMFD · Traditional Marlow Surgical Technologies, Inc.01/16/1997SE
K963031GenxcatheterMFD · Traditional Genx Intl., Inc.10/21/1996SE

More from Genx Intl., Inc.

510(k)DeviceDecision
K982630Medworks Visualization Insemination CatheterMFD · Traditional 01/14/1999SE
K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit…EZL · Special 08/20/1998SE

Questions and answers

When was Medworks Insemination Catheter cleared by the FDA?

Medworks Insemination Catheter (K982628) received a 510(k) decision of Substantially Equivalent on August 21, 1998, 24 days after the submission was received.

What is the product code of K982628?

The FDA product code is MFD – Cannula, Intrauterine Insemination, a Class II (moderate risk) device regulated under 21 CFR 884.5250.