Product code MFD— Obstetrics/Gynecology

FDA has cleared 29 devices under product code MFD between 1991 and 2002, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20021 clearance
• 20011 clearance
• 19992 clearances
• 19982 clearances
• 19974 clearances
• 19963 clearances
• 19955 clearances
• 19943 clearances
• 19934 clearances
• 19921 clearance
• 19913 clearances

• Life-Tech Intl., Inc.4 clearances
• Select Medical Systems, Inc.2 clearances
• Medworks Corp.2 clearances
• Marlo Surgical Technology2 clearances
• Life Technologies, Inc.2 clearances
• Cook Ob/Gyn2 clearances
• A & A Medical, Inc.2 clearances
• Wallach Surgical Devices, Inc.1 clearance
• Unimar, Inc.1 clearance
• Rocket Medical Plc1 clearance

• K021438 — INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik Gottingen·2002-07-16
• K012935 — THECURVE, ITEM 507Select Medical Systems, Inc.·2001-10-11
• K984306 — `THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.·1999-03-01
• K982630 — MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.·1999-01-14
• K982628 — MEDWORKS INSEMINATION CATHETERMedworks Corp.·1998-08-21
• K980061 — EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical Plc·1998-03-02
• K972823 — MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETERA & A Medical, Inc.·1997-10-10
• K972245 — TOM CAT F.L., TOM CAT S.L.A & A Medical, Inc.·1997-08-06
• K970750 — MICROSPAN INSEMINATION SYSTEMImagyn Medical, Inc.·1997-05-05
• K964848 — WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CMMarlow Surgical Technologies, Inc.·1997-01-16
• K963031 — GENXCATHETERGenx Intl., Inc.·1996-10-21
• K962273 — MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NSTMarlo Surgical Technology·1996-07-31
• K940176 — ACKRAD IUI SET FOR INTRAUTERINE INSEMINATIONAckrad Laboratories·1996-04-23
• K954398 — INSEMI-CATH IICook Urological, Inc.·1995-12-19
• K954099 — SELECT IUISelect Medical Systems, Inc.·1995-11-22
• K953719 — HUMAN TUBAL FLUIDLife Technologies, Inc.·1995-11-06
• K951835 — MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATELife Technologies, Inc.·1995-08-11
• K932993 — INTRAUTERINE CATHETER AND INTRODUCERConceptus, Inc.·1995-01-06
• K921518 — LIFETEK IUI CATHETERLifetek Medical, Inc.·1994-05-10
• K931630 — INSEMI-CATHCook Ob/Gyn·1994-04-19
• K914541 — SPERM MAINTENANCE MEDIUM WITH GLYCEROLIrvine Scientific·1994-02-03
• K923612 — MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINELife-Tech Intl., Inc.·1993-09-07
• K923634 — MODIFIED F-10 CULTURE MEDIUMLife-Tech Intl., Inc.·1993-09-07
• K923651 — DISTILLED WATERLife-Tech Intl., Inc.·1993-09-07
• K923652 — DULBECCO'S PHOSPHATE BUFFERED SALINELife-Tech Intl., Inc.·1993-09-07
• K914150 — JANSEN-ANDERSON INSEMINATION SETCook Ob/Gyn·1992-09-02
• K910577 — EDWARDS-WALLACE BOURNE HALL CATHETERMarlo Surgical Technology·1991-05-09
• K910317 — UNI-SEM(TM)Unimar, Inc.·1991-05-01
• K905764 — SEMINORPromedex, Inc.·1991-03-12