FDA 510(k) Obstetrics & Gynecology Devices
FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview
FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.
Key categories:
- Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
- Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
- Breast pumps and lactation aids - electric and manual breast pumps
- Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
- Pregnancy test systems - hCG detection devices for professional and home use
4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3162 Obstetrics & Gynecology devices
Cleared
Feb 14, 1997
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
HET
Laparoscope, Gynecologic (and Accessories)
368d
Cleared
Feb 14, 1997
EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
HGX
Pump, Breast, Powered
358d
Cleared
Feb 14, 1997
TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
HHP
Table, Obstetrical, Manual (and Accessories)
164d
Cleared
Feb 14, 1997
TRUSTEX COLA FLAVORD CONDOM
HIS
Condom
88d
Cleared
Feb 14, 1997
TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
HIS
Condom
88d
Cleared
Feb 13, 1997
TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR
HIS
Condom
90d
Cleared
Feb 11, 1997
SAFE KNIGHTS
HIS
Condom
456d
Cleared
Feb 10, 1997
EVERT-IT
HGY
Pump, Breast, Non-powered
206d
Cleared
Feb 07, 1997
RIGID FIBER OPTIC LAPAROSCOPE
HET
Laparoscope, Gynecologic (and Accessories)
241d
Cleared
Jan 31, 1997
CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
MKO
Falloposcope
214d
Cleared
Jan 31, 1997
IMAGYN FALLOPOSCOPY SYSTEM
MKO
Falloposcope
147d
Cleared
Jan 30, 1997
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
HET
Laparoscope, Gynecologic (and Accessories)
86d
Cleared
Jan 29, 1997
KSEA PUNCTURE CANNULA
HET
Laparoscope, Gynecologic (and Accessories)
86d
Cleared
Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
HIS
Condom
163d
Cleared
Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
HIS
Condom
163d
Cleared
Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
LTZ
Condom With Nonoxynol-9
163d
Cleared
Jan 22, 1997
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
KXO
Monitor, Pressure, Intrauterine
86d
Cleared
Jan 17, 1997
FEMRX MORCELLATOR SYSTEM
HET
Laparoscope, Gynecologic (and Accessories)
113d
Cleared
Jan 16, 1997
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
MFD
Cannula, Intrauterine Insemination
44d
Cleared
Jan 13, 1997
SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
HGX
Pump, Breast, Powered
70d
Cleared
Jan 10, 1997
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
HIF
Insufflator, Laparoscopic
184d
Cleared
Jan 10, 1997
HYSTERO CO2-PNEU 2221
HIG
Insufflator, Hysteroscopic
87d
Cleared
Jan 10, 1997
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
HET
Laparoscope, Gynecologic (and Accessories)
65d
Cleared
Jan 09, 1997
NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
HIF
Insufflator, Laparoscopic
412d
Cleared
Dec 20, 1996
KSEA UNIMAT PLUS
HET
Laparoscope, Gynecologic (and Accessories)
79d
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