FDA 510(k) Applications for Medical Device Product Code "MFD"
(Cannula, Intrauterine Insemination)

FDA 510(k) Number Applicant Device Name Decision Date
K972823 A & A MEDICAL, INC. MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER 10/10/1997
K972245 A & A MEDICAL, INC. TOM CAT F.L., TOM CAT S.L. 08/06/1997
K940176 ACKRAD LABORATORIES ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION 04/23/1996
K963031 GENX INTL., INC. GENXCATHETER 10/21/1996
K970750 IMAGYN MEDICAL, INC. MICROSPAN INSEMINATION SYSTEM 05/05/1997
K021438 LABOTECT LABOR-TECHNIK GOTTINGEN INSEMINATION CATHETER, MODEL 320301 07/16/2002
K962273 MARLO SURGICAL TECHNOLOGY MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST 07/31/1996
K964848 MARLOW SURGICAL TECHNOLOGIES, INC. WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM 01/16/1997
K982628 MEDWORKS CORP. MEDWORKS INSEMINATION CATHETER 08/21/1998
K982630 MEDWORKS CORP. MEDWORKS VISUALIZATION INSEMINATION CATHETER 01/14/1999
K980061 ROCKET MEDICAL PLC EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER 03/02/1998
K012935 SELECT MEDICAL SYSTEMS, INC. THECURVE, ITEM 507 10/11/2001
K984306 WALLACH SURGICAL DEVICES, INC. `THE INSEMINATOR' (PROPOSED) 03/01/1999


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