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
3156 Obstetrics & Gynecology devices
Cleared
Jul 09, 2001
US SENSOR #CG-930P
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
206d
Cleared
Jul 09, 2001
MMODIFICATION TO LAMINARIA
HDY
Dilator, Cervical, Hygroscopic-laminaria
54d
Cleared
Jul 02, 2001
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
76d
Cleared
Jun 13, 2001
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
MTW
System, Water, Reproduction, Assisted, And Purification
20d
Cleared
Jun 12, 2001
MM-87 MOTOR-DRIVE MANIPULATOR
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
34d
Cleared
Jun 11, 2001
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
90d
Cleared
May 29, 2001
OB-1 FETAL MONITOR
HGM
System, Monitoring, Perinatal
29d
Cleared
May 16, 2001
BALLOON CANNULA, SHORT, MODEL R65-985
HET
Laparoscope, Gynecologic (and Accessories)
84d
Cleared
May 11, 2001
CG-900P FETAL/MATERNAL MONITOR
HGM
System, Monitoring, Perinatal
74d
Cleared
May 03, 2001
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
MQL
Media, Reproductive
17d
Cleared
May 02, 2001
GLOBAL BY BLASTOCYST MEDIA
MQL
Media, Reproductive
103d
Cleared
Apr 30, 2001
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
HFW
Clamp, Umbilical
41d
Cleared
Apr 27, 2001
SONICAID SYSTEM 8002
HGM
System, Monitoring, Perinatal
633d
Cleared
Apr 09, 2001
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
12d
Cleared
Apr 04, 2001
MINI FIBER ENDOSCOPES
HET
Laparoscope, Gynecologic (and Accessories)
153d
Cleared
Mar 22, 2001
BLASTASSIST SYSTEM
MQL
Media, Reproductive
163d
Cleared
Mar 22, 2001
SYNVITRO FLUSH
MQL
Media, Reproductive
163d
Cleared
Mar 22, 2001
SUPRASPERM SYSTEM
MQL
Media, Reproductive
141d
Cleared
Mar 16, 2001
MN-4 COARSE MANIPULATOR
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
44d
Cleared
Mar 15, 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
30d
Cleared
Mar 09, 2001
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
NUC
Lubricant, Personal
87d
Cleared
Mar 02, 2001
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
HIF
Insufflator, Laparoscopic
407d
Cleared
Feb 22, 2001
TAUT-INSUFFLATION NEEDLE
HIF
Insufflator, Laparoscopic
83d
Cleared
Feb 21, 2001
STRYKER HEATED INSUFFLATOR TUBE SET
HIF
Insufflator, Laparoscopic
75d
Cleared
Feb 20, 2001
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
HGI
Electrocautery, Gynecologic (and Accessories)
90d
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