Cleared Traditional

MEDWORKS INSEMINATION CATHETER

K982628 · Medworks Corp. · Obstetrics & Gynecology
Aug 1998
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K982628 is an FDA 510(k) clearance for the MEDWORKS INSEMINATION CATHETER, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Medworks Corp. (Pawtucket, US). The FDA issued a Cleared decision on August 21, 1998, 24 days after receiving the submission on July 28, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K982628 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MFD — Cannula, Intrauterine Insemination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5250

Similar Devices — MFD Cannula, Intrauterine Insemination

All 28
INSEMINATION CATHETER, MODEL 320301
K021438 · Labotect Labor-Technik Gottingen · Jul 2002
THECURVE, ITEM 507
K012935 · Select Medical Systems, Inc. · Oct 2001
`THE INSEMINATOR' (PROPOSED)
K984306 · Wallach Surgical Devices, Inc. · Mar 1999
MEDWORKS VISUALIZATION INSEMINATION CATHETER
K982630 · Medworks Corp. · Jan 1999
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
K980061 · Rocket Medical Plc · Mar 1998
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
K972823 · A & A Medical, Inc. · Oct 1997