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
3155 Obstetrics & Gynecology devices
Cleared
Jan 13, 2005
ICSI-100
MQL
Media, Reproductive
64d
Cleared
Dec 23, 2004
FEMSPEC DISPOSABLE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
177d
Cleared
Dec 22, 2004
GYNECARE PROLENE FASTENER SYSTEM
PBQ
Fixation, Non-absorbable Or Absorbable, For Pelvic Use
89d
Cleared
Dec 15, 2004
GERBER DOUBLE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
36d
Cleared
Nov 30, 2004
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
HIS
Condom
186d
Cleared
Nov 30, 2004
VAG O SPECULUM, MODELS VS1, VM1, VL1
HIB
Speculum, Vaginal, Nonmetal
35d
Cleared
Nov 23, 2004
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
49d
Cleared
Nov 22, 2004
MEDICULT IVM SYSTEM
MQL
Media, Reproductive
193d
Cleared
Nov 22, 2004
MORTON IUI CATHETERS
MQF
Catheter, Assisted Reproduction
173d
Cleared
Nov 17, 2004
MINIMESH POLYPROPYLENE MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
154d
Cleared
Nov 08, 2004
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
HHT
Spatula, Cervical, Cytological
52d
Cleared
Oct 07, 2004
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
HIH
Hysteroscope (and Accessories)
98d
Cleared
Oct 04, 2004
ENDOMETRIAL SAMPLING SYRINGE
HHK
Curette, Suction, Endometrial (and Accessories)
250d
Cleared
Oct 01, 2004
INTRAUTERINE VENOGRAM NEEDLE SET
LKF
Cannula, Manipulator/injector, Uterine
161d
Cleared
Sep 29, 2004
THE STRIPPER PGD
MQH
Microtools, Assisted Reproduction (pipettes)
124d
Cleared
Sep 28, 2004
FLO-ASSISTANT
HIF
Insufflator, Laparoscopic
110d
Cleared
Sep 24, 2004
PERSONAL LUBRICATING GEL
NUC
Lubricant, Personal
147d
Cleared
Sep 24, 2004
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
HIS
Condom
79d
Cleared
Sep 08, 2004
ECHOSAMPLER
HFF
Aspirator, Endometrial
120d
Cleared
Sep 02, 2004
CADENCE, MODELS 2001 AND 2002
HGM
System, Monitoring, Perinatal
148d
Cleared
Aug 09, 2004
CRYOTIP
MQH
Microtools, Assisted Reproduction (pipettes)
60d
Cleared
Jul 29, 2004
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
HIF
Insufflator, Laparoscopic
255d
Cleared
Jul 09, 2004
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
HEB
Tampon, Menstrual, Unscented
81d
Cleared
Jul 09, 2004
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
HET
Laparoscope, Gynecologic (and Accessories)
52d
Cleared
Jun 25, 2004
MEDIA CULTURE SYSTEM
MQL
Media, Reproductive
116d
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