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 22, 2004
SOFTSEAL HSG CATHETER
LKF
Cannula, Manipulator/injector, Uterine
148d
Cleared
Jun 22, 2004
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
84d
Cleared
Jun 17, 2004
HSG CATHETER SET
LKF
Cannula, Manipulator/injector, Uterine
51d
Cleared
May 28, 2004
PH BUFFERING PLASTIC APPLICATOR TAMPON
HEB
Tampon, Menstrual, Unscented
471d
Cleared
May 28, 2004
KOLPEXIN SPHERE
HHW
Pessary, Vaginal
275d
Cleared
May 25, 2004
SONOTRAX ULTRASONIC POCKET DOPPLER
KNG
Monitor, Ultrasonic, Fetal
90d
Cleared
May 17, 2004
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
HIH
Hysteroscope (and Accessories)
90d
Cleared
May 17, 2004
AMS PERIGEE SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
69d
Cleared
May 07, 2004
G-FREEZEKIT BLAST
MQL
Media, Reproductive
298d
Cleared
May 07, 2004
G-THAWKIT BLAST
MQL
Media, Reproductive
298d
Cleared
May 07, 2004
G-OOCYTE
MQL
Media, Reproductive
235d
Cleared
May 07, 2004
G-PGD
MQL
Media, Reproductive
221d
Cleared
May 03, 2004
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
84d
Cleared
Apr 28, 2004
K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
NUC
Lubricant, Personal
77d
Cleared
Apr 27, 2004
CAUTION CONDOMS
LTZ
Condom With Nonoxynol-9
172d
Cleared
Apr 27, 2004
DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
HIS
Condom
91d
Cleared
Apr 26, 2004
MULTIBLAST MEDIUM
MQL
Media, Reproductive
117d
Cleared
Apr 22, 2004
AMS APOGEE VAULT SUSPENSION SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
51d
Cleared
Apr 20, 2004
PERSONAL WARMING LUBRICANT
HIS
Condom
95d
Cleared
Apr 09, 2004
FINE SURGICAL CIRCUMCISION CLAMP
HFX
Clamp, Circumcision
88d
Cleared
Apr 05, 2004
EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
HGY
Pump, Breast, Non-powered
207d
Cleared
Apr 05, 2004
K-Y BRAND WARMING JELLY PERSONAL LUBRICANT
NUC
Lubricant, Personal
70d
Cleared
Mar 29, 2004
DUREX FLAVORED LATEX CONDOM
HIS
Condom
252d
Cleared
Mar 24, 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
23d
Cleared
Mar 23, 2004
SYDNEY IVF PVP
MQL
Media, Reproductive
334d
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