Atlas FDA

MFD

29 FDA 510(k) clearances · Product code

89 daysmedian time to decision
770 days90th percentile
29clearances measured

FDA profile

Official device name
Cannula, Intrauterine Insemination
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5250
Medical specialty
Obstetrics/Gynecology
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RecordFirmDate
INSEMINATION CATHETER, MODEL 320301 (K021438)Labotect Labor-Technik Gottingen2002-07-16
THECURVE, ITEM 507 (K012935)Select Medical Systems, Inc.2001-10-11
`THE INSEMINATOR' (PROPOSED) (K984306)Wallach Surgical Devices, Inc.1999-03-01
MEDWORKS VISUALIZATION INSEMINATION CATHETER (K982630)Medworks Corp.1999-01-14
MEDWORKS INSEMINATION CATHETER (K982628)Medworks Corp.1998-08-21
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER (K980061)Rocket Medical Plc1998-03-02
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER (K972823)A & A Medical, Inc.1997-10-10
TOM CAT F.L., TOM CAT S.L. (K972245)A & A Medical, Inc.1997-08-06
MICROSPAN INSEMINATION SYSTEM (K970750)Imagyn Medical, Inc.1997-05-05
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM (K964848)Marlow Surgical Technologies, Inc.1997-01-16
GENXCATHETER (K963031)Genx Intl., Inc.1996-10-21
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST (K962273)Marlo Surgical Technology1996-07-31
ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION (K940176)Ackrad Laboratories1996-04-23
INSEMI-CATH II (K954398)Cook Urological, Inc.1995-12-19
SELECT IUI (K954099)Select Medical Systems, Inc.1995-11-22
HUMAN TUBAL FLUID (K953719)Life Technologies, Inc.1995-11-06
MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE (K951835)Life Technologies, Inc.1995-08-11
INTRAUTERINE CATHETER AND INTRODUCER (K932993)Conceptus, Inc.1995-01-06
LIFETEK IUI CATHETER (K921518)Lifetek Medical, Inc.1994-05-10
INSEMI-CATH (K931630)Cook Ob/Gyn1994-04-19
SPERM MAINTENANCE MEDIUM WITH GLYCEROL (K914541)Irvine Scientific1994-02-03
MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE (K923612)Life-Tech Intl., Inc.1993-09-07
MODIFIED F-10 CULTURE MEDIUM (K923634)Life-Tech Intl., Inc.1993-09-07
DULBECCO'S PHOSPHATE BUFFERED SALINE (K923652)Life-Tech Intl., Inc.1993-09-07
DISTILLED WATER (K923651)Life-Tech Intl., Inc.1993-09-07
JANSEN-ANDERSON INSEMINATION SET (K914150)Cook Ob/Gyn1992-09-02
EDWARDS-WALLACE BOURNE HALL CATHETER (K910577)Marlo Surgical Technology1991-05-09
UNI-SEM(TM) (K910317)Unimar, Inc.1991-05-01
SEMINOR (K905764)Promedex, Inc.1991-03-12

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