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
Jul 16, 2002
THE DIVACUP MENSTRUAL SOLUTION
HHE
Cup, Menstrual
78d
Cleared
Jul 16, 2002
INSEMINATION CATHETER, MODEL 320301
MFD
Cannula, Intrauterine Insemination
71d
Cleared
Jul 16, 2002
TAGG DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
41d
Cleared
Jul 12, 2002
ENDOCERVICAL BLOCK NEEDLE
HEE
Set, Anesthesia, Paracervical
86d
Cleared
Jul 12, 2002
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
HIB
Speculum, Vaginal, Nonmetal
52d
Cleared
Jul 05, 2002
EMBRYO BIOPSY MEDIUM
MQL
Media, Reproductive
67d
Cleared
Jun 25, 2002
UHI-3 HIGH FLOW INSUFFLATION UNIT
HIF
Insufflator, Laparoscopic
188d
Cleared
Jun 25, 2002
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
HDY
Dilator, Cervical, Hygroscopic-laminaria
88d
Cleared
Jun 19, 2002
WORKBENCH BY
MQG
Accessory, Assisted Reproduction
119d
Cleared
Jun 19, 2002
GLO-SPEC I, II AND III
HIB
Speculum, Vaginal, Nonmetal
86d
Cleared
Jun 19, 2002
LEESPEC DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
82d
Cleared
Jun 12, 2002
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
LTZ
Condom With Nonoxynol-9
281d
Cleared
Jun 12, 2002
K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
NUC
Lubricant, Personal
90d
Cleared
Jun 03, 2002
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
HFW
Clamp, Umbilical
90d
Cleared
May 31, 2002
INPATH E2 COLLECTOR
HHT
Spatula, Cervical, Cytological
242d
Cleared
May 24, 2002
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
HHK
Curette, Suction, Endometrial (and Accessories)
87d
Cleared
May 21, 2002
SIB CATHETER, MODEL 61-7005
LKF
Cannula, Manipulator/injector, Uterine
29d
Cleared
May 16, 2002
MTI ST#1 SILICONE PESSARY
HHW
Pessary, Vaginal
90d
Cleared
May 15, 2002
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
HIS
Condom
77d
Cleared
May 15, 2002
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
HIB
Speculum, Vaginal, Nonmetal
70d
Cleared
May 15, 2002
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS
MQG
Accessory, Assisted Reproduction
44d
Cleared
May 09, 2002
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
79d
Cleared
May 09, 2002
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
HGM
System, Monitoring, Perinatal
30d
Cleared
May 03, 2002
THE NURTURE III BREAST PUMP
HGX
Pump, Breast, Powered
88d
Cleared
Apr 29, 2002
BUSSE UMBILICAL CORD CLAMP CUTTER
HFW
Clamp, Umbilical
28d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices