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
4499
Total
4485
Cleared
168d
Avg (2y)
1976
Since
1727 Obstetrics & Gynecology devices
Cleared
Jun 10, 1997
O.B. APPLICATOR TAMPONS
HEB
Tampon, Menstrual, Unscented
85d
Cleared
Jun 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
65d
Cleared
Jun 05, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
HGM
System, Monitoring, Perinatal
71d
Cleared
May 27, 1997
KSEA CO2 ENDOFLATOR
HIF
Insufflator, Laparoscopic
270d
Cleared
May 05, 1997
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
HET
Laparoscope, Gynecologic (and Accessories)
139d
Cleared
Apr 22, 1997
CARD GUARD MODEL CG-900
HGM
System, Monitoring, Perinatal
439d
Cleared
Apr 09, 1997
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
LKF
Cannula, Manipulator/injector, Uterine
58d
Cleared
Mar 20, 1997
CANNULA
HET
Laparoscope, Gynecologic (and Accessories)
87d
Cleared
Mar 18, 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
HET
Laparoscope, Gynecologic (and Accessories)
62d
Cleared
Mar 10, 1997
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
HHW
Pessary, Vaginal
83d
Cleared
Mar 06, 1997
ROLLER ELECTRODE
HIH
Hysteroscope (and Accessories)
526d
Cleared
Mar 04, 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
HET
Laparoscope, Gynecologic (and Accessories)
50d
Cleared
Feb 21, 1997
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
HGM
System, Monitoring, Perinatal
86d
Cleared
Jan 29, 1997
KSEA PUNCTURE CANNULA
HET
Laparoscope, Gynecologic (and Accessories)
86d
Cleared
Jan 22, 1997
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
KXO
Monitor, Pressure, Intrauterine
86d
Cleared
Jan 10, 1997
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
HIF
Insufflator, Laparoscopic
184d
Cleared
Jan 10, 1997
HYSTERO CO2-PNEU 2221
HIG
Insufflator, Hysteroscopic
87d
Cleared
Dec 20, 1996
KSEA UNIMAT PLUS
HET
Laparoscope, Gynecologic (and Accessories)
79d
Cleared
Dec 19, 1996
KSEA UNIMAT PLUS
HET
Laparoscope, Gynecologic (and Accessories)
78d
Cleared
Dec 10, 1996
KSEA THERMOCOAGULATOR (MODEL 265100 20)
HGI
Electrocautery, Gynecologic (and Accessories)
76d
Cleared
Dec 06, 1996
KSEA THERMOFLATOR (MODEL 26 4320 20)
HIF
Insufflator, Laparoscopic
396d
Cleared
Nov 26, 1996
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
HGI
Electrocautery, Gynecologic (and Accessories)
343d
Cleared
Nov 19, 1996
KOH COLPOTOMIZER SYSTEM
HEW
Culdoscope (and Accessories)
431d
Cleared
Nov 19, 1996
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
HIF
Insufflator, Laparoscopic
119d
Cleared
Nov 13, 1996
KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
HIH
Hysteroscope (and Accessories)
202d
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