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
Apr 19, 1995
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
HIG
Insufflator, Hysteroscopic
377d
Cleared
Apr 14, 1995
CO2 INSUFFLATOR 1100
HIF
Insufflator, Laparoscopic
830d
Cleared
Apr 14, 1995
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
HIS
Condom
248d
Cleared
Apr 11, 1995
HYS-SURGIFLATOR
HIG
Insufflator, Hysteroscopic
945d
Cleared
Apr 11, 1995
LUMIN
LKF
Cannula, Manipulator/injector, Uterine
267d
Cleared
Mar 31, 1995
R-MED DISPOSABLE PLUG
HET
Laparoscope, Gynecologic (and Accessories)
315d
Cleared
Mar 30, 1995
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
HET
Laparoscope, Gynecologic (and Accessories)
156d
Cleared
Mar 29, 1995
CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP
HGM
System, Monitoring, Perinatal
754d
Cleared
Mar 29, 1995
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
HET
Laparoscope, Gynecologic (and Accessories)
247d
Cleared
Mar 23, 1995
ENDOLAP INSUFFLATOR TUBING SET
HIF
Insufflator, Laparoscopic
63d
Cleared
Mar 22, 1995
ULTIMATES SILK GLIDE TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
21d
Cleared
Mar 21, 1995
BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.
HET
Laparoscope, Gynecologic (and Accessories)
651d
Cleared
Mar 21, 1995
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
HGI
Electrocautery, Gynecologic (and Accessories)
293d
Cleared
Mar 21, 1995
KSEA SEMM TISSUR PUNCH
HET
Laparoscope, Gynecologic (and Accessories)
267d
Cleared
Mar 21, 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
HET
Laparoscope, Gynecologic (and Accessories)
103d
Cleared
Mar 16, 1995
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
HET
Laparoscope, Gynecologic (and Accessories)
66d
Cleared
Mar 15, 1995
3000 ELECTRONIC INSUFFLATOR MODIFICATION
HIF
Insufflator, Laparoscopic
568d
Cleared
Mar 06, 1995
CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
HET
Laparoscope, Gynecologic (and Accessories)
658d
Cleared
Mar 06, 1995
THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM
HET
Laparoscope, Gynecologic (and Accessories)
342d
Cleared
Mar 01, 1995
MODEL IM77 INTRAPARTUM FETAL MONITOR
HGM
System, Monitoring, Perinatal
370d
Cleared
Feb 28, 1995
CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
HET
Laparoscope, Gynecologic (and Accessories)
657d
Cleared
Feb 28, 1995
CERVEX-BRUSH PAP KIT
HHT
Spatula, Cervical, Cytological
337d
Cleared
Feb 28, 1995
TROCAR AND CANNULA ACCESSORY
HET
Laparoscope, Gynecologic (and Accessories)
97d
Cleared
Feb 27, 1995
HASSON STABILIZING ACCESS CANNULA (SAC)
HET
Laparoscope, Gynecologic (and Accessories)
252d
Cleared
Feb 21, 1995
A4722 OLYMPUS OPTICAL OBTURATOR
HIH
Hysteroscope (and Accessories)
46d
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