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
3153 Obstetrics & Gynecology devices
Cleared
Dec 15, 2006
OCTAX LASER SHOT SYSTEM
MRX
System, Assisted Reproduction Laser
109d
Cleared
Dec 08, 2006
K-Y BRAND INTRIGUE
NUC
Lubricant, Personal
80d
Cleared
Dec 07, 2006
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
146d
Cleared
Dec 04, 2006
INTIMOL
NUC
Lubricant, Personal
192d
Cleared
Nov 22, 2006
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
HEB
Tampon, Menstrual, Unscented
78d
Cleared
Oct 27, 2006
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
67d
Cleared
Oct 20, 2006
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
HGI
Electrocautery, Gynecologic (and Accessories)
129d
Cleared
Oct 13, 2006
PRE' VAGINAL LUBRICANT
PEB
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
499d
Cleared
Oct 13, 2006
WALLACE ARTIFICIAL INSEMINATION CATHETER
LKF
Cannula, Manipulator/injector, Uterine
120d
Cleared
Oct 13, 2006
VERESS CANNULA AND MODULAR VERESS CANNULA
HET
Laparoscope, Gynecologic (and Accessories)
81d
Cleared
Oct 06, 2006
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
MQG
Accessory, Assisted Reproduction
617d
Cleared
Oct 05, 2006
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
HIS
Condom
22d
Cleared
Oct 02, 2006
SPERMSLOW
MQL
Media, Reproductive
160d
Cleared
Sep 19, 2006
HIERSPEC SPECULUM
HIB
Speculum, Vaginal, Nonmetal
127d
Cleared
Sep 12, 2006
ZEUS MALE CONDOM APPLICATOR
HIS
Condom
396d
Cleared
Aug 24, 2006
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
HET
Laparoscope, Gynecologic (and Accessories)
24d
Cleared
Aug 17, 2006
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
MQL
Media, Reproductive
92d
Cleared
Aug 15, 2006
PLAYTEX EMBRACE PETITE BREAST PUMP
HGX
Pump, Breast, Powered
124d
Cleared
Aug 07, 2006
CO-1000 COLPOSCOPE, MULTIPLE
HEX
Colposcope (and Colpomicroscope)
89d
Cleared
Aug 01, 2006
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
HEB
Tampon, Menstrual, Unscented
62d
Cleared
Jul 31, 2006
G-LIX TISSUE GRASPER
HET
Laparoscope, Gynecologic (and Accessories)
87d
Cleared
Jul 28, 2006
FEMECC ENDOCERVICAL CURETTE
PCF
Sampler, Endocervical
170d
Cleared
Jul 28, 2006
BIOPSY MEDIUM, MODEL REF 1062
MQL
Media, Reproductive
109d
Cleared
Jul 21, 2006
VERESURE BELL
HIF
Insufflator, Laparoscopic
64d
Cleared
Jul 14, 2006
INVITRO MATURATION MEDIA
MQL
Media, Reproductive
196d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices