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
3179 Obstetrics & Gynecology devices
Cleared
Mar 14, 1978
VAGINAL RETRACTOR
HDL
Retractor, Vaginal
11d
Cleared
Mar 02, 1978
DISPLAY SYSTEM MODEL 428
HGM
System, Monitoring, Perinatal
27d
Cleared
Mar 02, 1978
FETAL MONITOR MODEL 112
HGM
System, Monitoring, Perinatal
27d
Cleared
Mar 02, 1978
TAMPON, RELY MODIFIED
HEB
Tampon, Menstrual, Unscented
17d
Cleared
Jan 26, 1978
TAMPON, HEAVY DUTY, & STICK
HIL
Tampon, Menstrual, Scented, Scented-deodorized
14d
Cleared
Jan 05, 1978
INSUFFLATOR, MODEL G100 & 200
HIF
Insufflator, Laparoscopic
23d
Cleared
Jan 03, 1978
MINICLAMPS, STABILIZ., FALLOPIAN TUBE
HCZ
Forceps, Surgical, Gynecological
28d
Cleared
Jan 03, 1978
CANNULA, PERFUSION, FALLOPIAN TUBE
LKF
Cannula, Manipulator/injector, Uterine
28d
Cleared
Dec 20, 1977
LAPAROSCOPY CONSOLE MODEL VIII
HET
Laparoscope, Gynecologic (and Accessories)
12d
Cleared
Dec 13, 1977
PROBE, COAGULATION ACCESSORY
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
8d
Cleared
Nov 30, 1977
LAPAROSCOPE W/REMOVABLE OPTICS
HET
Laparoscope, Gynecologic (and Accessories)
5d
Cleared
Nov 21, 1977
CAMERA ADAPTER FOR ENDOSCOPES
HET
Laparoscope, Gynecologic (and Accessories)
35d
Cleared
Nov 17, 1977
ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.
HHK
Curette, Suction, Endometrial (and Accessories)
7d
Cleared
Nov 07, 1977
SILASTIC BRAND INTRAVAGINAL TARSETTE
HHW
Pessary, Vaginal
87d
Cleared
Oct 25, 1977
12MM SELF-SEALING TROCAR & CANNULA
HET
Laparoscope, Gynecologic (and Accessories)
8d
Cleared
Oct 25, 1977
8MM SELF-SEALING TROCAR & CANNULA
HET
Laparoscope, Gynecologic (and Accessories)
8d
Cleared
Oct 25, 1977
TUBAL OCCLUSION INSERTER/LAPAROSCOPE
HET
Laparoscope, Gynecologic (and Accessories)
8d
Cleared
Oct 25, 1977
DUAL INCISION TUBAL OCCLUS. BAND APPLI.
HET
Laparoscope, Gynecologic (and Accessories)
8d
Cleared
Oct 25, 1977
SINGLE INCISION TUBAL OCCLU. BAND APPL.
HET
Laparoscope, Gynecologic (and Accessories)
8d
Cleared
Oct 25, 1977
8MM TROCAR & CANNUAL W/STOPCOCK
HET
Laparoscope, Gynecologic (and Accessories)
8d
Cleared
Sep 20, 1977
PETITES BETWEEN-PERIOD PROTECTORS
HHL
Pad, Menstrual, Scented, Scented-deodorized
39d
Cleared
Sep 20, 1977
SILASTIC BRAND OBSTETRICAL VACUUM CUP
HDB
Extractor, Vacuum, Fetal
36d
Cleared
Aug 25, 1977
FETAL MONITORING SYSTEM
HGM
System, Monitoring, Perinatal
14d
Cleared
Aug 25, 1977
SPIRAL SCALP ELECTRODE, 14499A
HGP
Electrode, Circular (spiral), Scalp And Applicator
13d
Cleared
Aug 04, 1977
ARTIUS SYSTEM
HGL
Transducer, Ultrasonic, Obstetric
41d
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