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
3161 Obstetrics & Gynecology devices
Cleared
Dec 12, 1997
MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M
HET
Laparoscope, Gynecologic (and Accessories)
73d
Cleared
Dec 12, 1997
SWIFT DELIVERY PRODUCT #300
HDB
Extractor, Vacuum, Fetal
77d
Cleared
Dec 12, 1997
HOSPITAL'S CLAMP
HFW
Clamp, Umbilical
30d
Cleared
Dec 12, 1997
HOSPITAL'S SPEC
HIB
Speculum, Vaginal, Nonmetal
30d
Cleared
Dec 12, 1997
CIRCUMCISION TRAY, CAT. NO. 70340
HFX
Clamp, Circumcision
28d
Cleared
Dec 11, 1997
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
HIG
Insufflator, Hysteroscopic
336d
Cleared
Dec 11, 1997
EXPRESSE AND PREMIER POWERED BREAST PUMPS
HGX
Pump, Breast, Powered
86d
Cleared
Dec 09, 1997
SURGIFLATOR-30
HIF
Insufflator, Laparoscopic
90d
Cleared
Dec 02, 1997
MVM 3.3 MM MICROENDOSCOPE
HET
Laparoscope, Gynecologic (and Accessories)
90d
Cleared
Nov 26, 1997
ENDOCERVICAL BLOCK NEEDLE
HEE
Set, Anesthesia, Paracervical
61d
Cleared
Nov 26, 1997
PERSONAL LUBRICATING LIQUID
HIS
Condom
54d
Cleared
Nov 25, 1997
ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR
HEW
Culdoscope (and Accessories)
393d
Cleared
Nov 24, 1997
VERY PRIVATE INTIMATE MOISTURE
HIS
Condom
193d
Cleared
Nov 24, 1997
PRE-FILLED SYRINGE FOR KOALA IUP
HFN
Transducer, Pressure, Intrauterine
54d
Cleared
Nov 20, 1997
KNIGHT LIGHT NONLUBRICATED CONDOM
HIS
Condom
651d
Cleared
Nov 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
HFO
Recorder, Pressure, Intrauterine
35d
Cleared
Nov 07, 1997
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
HET
Laparoscope, Gynecologic (and Accessories)
172d
Cleared
Nov 05, 1997
MICRO ELECTRODES
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
170d
Cleared
Nov 04, 1997
HYDROCHECK MICRO FILTER
HGX
Pump, Breast, Powered
267d
Cleared
Oct 22, 1997
MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212)
HIH
Hysteroscope (and Accessories)
188d
Cleared
Oct 22, 1997
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
LTZ
Condom With Nonoxynol-9
83d
Cleared
Oct 10, 1997
GALILEO HIGH RESOLUTION MICRO COUPLER
HET
Laparoscope, Gynecologic (and Accessories)
141d
Cleared
Oct 10, 1997
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
MFD
Cannula, Intrauterine Insemination
72d
Cleared
Oct 07, 1997
TACTYLON CONDOM
MOL
Condom, Synthetic
159d
Cleared
Oct 03, 1997
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
HGM
System, Monitoring, Perinatal
239d
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