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
Jun 27, 2003
BLASTFREEZE AND BLASTTHAW
MQL
Media, Reproductive
46d
Cleared
Jun 26, 2003
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
MQE
Needle, Assisted Reproduction
34d
Cleared
Jun 24, 2003
SYNVITRO HYADASE
MQL
Media, Reproductive
67d
Cleared
Jun 23, 2003
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
HIS
Condom
259d
Cleared
Jun 23, 2003
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
HHI
System, Abortion, Vacuum
90d
Cleared
Jun 23, 2003
EMBRYOGLUE
MQL
Media, Reproductive
84d
Cleared
Jun 09, 2003
KAISHOU VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
90d
Cleared
Jun 06, 2003
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
HGX
Pump, Breast, Powered
14d
Cleared
May 09, 2003
LAPAROSHIELD CONDITIONED INSUFFLATION SET
HIF
Insufflator, Laparoscopic
86d
Cleared
Apr 30, 2003
AQUASENS FLUID MONITORING SYSTEM
HIG
Insufflator, Hysteroscopic
13d
Cleared
Apr 24, 2003
BATTERY, RECHARGEABLE
HGM
System, Monitoring, Perinatal
90d
Cleared
Apr 22, 2003
WORRY-REMOVER IRRIGATOR
HED
Douche Apparatus, Vaginal, Therapeutic
106d
Cleared
Apr 17, 2003
LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
HIS
Condom
90d
Cleared
Apr 10, 2003
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
HET
Laparoscope, Gynecologic (and Accessories)
357d
Cleared
Apr 10, 2003
HYSTEREOSCOPY PUMP HM4
HIG
Insufflator, Hysteroscopic
258d
Cleared
Apr 08, 2003
MAS WITH OR WITHOUT SYRINGE
HHK
Curette, Suction, Endometrial (and Accessories)
305d
Cleared
Apr 08, 2003
PETIT SOPHIA
LHD
Device, Fertility Diagnostic, Proceptive
295d
Cleared
Apr 08, 2003
INVIGRA
HIS
Condom
245d
Cleared
Apr 08, 2003
ENHANCE HUMAN SERUM ALBUMIN
MQL
Media, Reproductive
22d
Cleared
Mar 25, 2003
LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
HIS
Condom
89d
Cleared
Mar 20, 2003
ENHANCE SPERM FREEZE
MQL
Media, Reproductive
66d
Cleared
Mar 10, 2003
KENDRO HERACELL 240 INCUBATOR
MQG
Accessory, Assisted Reproduction
146d
Cleared
Mar 03, 2003
PROMOTOR FINAL RINSE SPERM WASH MEDIUM
MQL
Media, Reproductive
70d
Cleared
Feb 24, 2003
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
HGM
System, Monitoring, Perinatal
90d
Cleared
Feb 19, 2003
PRECISION CAPILLARIES FOR MICROMANIPULATION
MQH
Microtools, Assisted Reproduction (pipettes)
57d
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