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
4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
Cleared
May 04, 2000
MEDI-CULT FLUSHING MEDIUM
MQL
Media, Reproductive
381d
Cleared
May 04, 2000
MEDI-CULT SPERM PREPARATION - MEDIUM
MQL
Media, Reproductive
381d
Not Cleared
Apr 28, 2000
EROS-CLITORAL THERAPY DEVICE (CTD)
NBV
Device, Engorgement, Clitoral
1d
Cleared
Apr 27, 2000
UMBICUT
HFW
Clamp, Umbilical
94d
Cleared
Apr 21, 2000
KSEA CHARDONNES MORCELLATION KNIFE
KOH
Instrument, Manual, General Obstetric-gynecologic
88d
Cleared
Apr 21, 2000
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
HIB
Speculum, Vaginal, Nonmetal
71d
Cleared
Apr 21, 2000
3D MANUAL COARSE MANIPULATOR MN-188NE
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
11d
Cleared
Apr 21, 2000
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
11d
Cleared
Apr 19, 2000
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
MQE
Needle, Assisted Reproduction
89d
Cleared
Apr 19, 2000
HYSTALOG HSG CATHETER
HES
Insufflator, Carbon-dioxide, Uterotubal (and Accessories)
76d
Cleared
Apr 19, 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
HIS
Condom
71d
Cleared
Apr 19, 2000
OIL FOR TISSUE CULTURE
MQL
Media, Reproductive
364d
Cleared
Apr 13, 2000
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
HEE
Set, Anesthesia, Paracervical
90d
Cleared
Apr 13, 2000
CORTEK MINI LAPAROSCOPE
HET
Laparoscope, Gynecologic (and Accessories)
83d
Cleared
Apr 06, 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
HIS
Condom
29d
Cleared
Apr 04, 2000
MEDISUL DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
56d
Cleared
Apr 03, 2000
INSUFFLATION NEEDLE, MODEL R65-933
HIF
Insufflator, Laparoscopic
89d
Cleared
Mar 31, 2000
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
HHK
Curette, Suction, Endometrial (and Accessories)
86d
Cleared
Mar 22, 2000
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
HFM
Monitor, Uterine Contraction, External (for Use In Clinic)
90d
Cleared
Mar 21, 2000
INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
HIS
Condom
75d
Cleared
Mar 21, 2000
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
HIS
Condom
75d
Cleared
Mar 21, 2000
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
HIS
Condom
75d
Cleared
Mar 21, 2000
OVES CERVICAL CAP
HDR
Cap, Cervical
120d
Cleared
Mar 21, 2000
MALE LATEX CONDOM WITH VANILLA FLAVOR
HIS
Condom
90d
Cleared
Mar 21, 2000
MALE LATEX CONDOM 56MM
HIS
Condom
90d
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