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
4478
Total
4465
Cleared
163d
Avg (2y)
1976
Since
849 Obstetrics & Gynecology devices
Cleared
Aug 23, 2019
CrossBay Cervical Dilator Catheter System
PON
Catheter, Balloon, Dilation Of Cervical Canal
147d
Cleared
Aug 23, 2019
1-Step Culture Medium
MQL
Media, Reproductive
123d
Cleared
Aug 01, 2019
JO Premium Jelly Original Personal Lubricant
NUC
Lubricant, Personal
87d
Cleared
Jul 26, 2019
RapidVit™ Oocyte, RapidWarm™ Oocyte
MQL
Media, Reproductive
221d
Cleared
Jul 22, 2019
CottonDay Tampon
HEB
Tampon, Menstrual, Unscented
292d
Cleared
Jul 19, 2019
KIDScore D3
PBH
Embryo Image Assessment System, Assisted Reproduction
290d
Cleared
Jul 16, 2019
Sage 2-in-1 Personal Lubricant and Moisturizer
NUC
Lubricant, Personal
167d
Cleared
Jul 16, 2019
iBreastExam
NKA
System, Documentation, Breast Lesion
132d
Cleared
Jul 15, 2019
Rael Tampon
HEB
Tampon, Menstrual, Unscented
285d
Cleared
Jul 08, 2019
GLISSANT Intimate Lubricant
NUC
Lubricant, Personal
248d
Cleared
Jul 08, 2019
ProVate Vaginal Support
HHW
Pessary, Vaginal
150d
Cleared
Jun 28, 2019
SureTouch Mobile Pressure Mapping System
NKA
System, Documentation, Breast Lesion
368d
Cleared
Jun 21, 2019
Vit Kit- Freeze NX and Vit Kit- Warm NX
MQL
Media, Reproductive
142d
Cleared
Jun 12, 2019
Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
HGX
Pump, Breast, Powered
257d
Cleared
Jun 12, 2019
Wallace Dual Lumen Oocyte Recovery System
MQE
Needle, Assisted Reproduction
29d
Cleared
Jun 06, 2019
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
HIH
Hysteroscope (and Accessories)
66d
Cleared
Jun 06, 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
HIH
Hysteroscope (and Accessories)
20d
Cleared
May 29, 2019
Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
KNG
Monitor, Ultrasonic, Fetal
260d
Cleared
May 24, 2019
Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
KNW
Instrument, Biopsy
94d
Cleared
May 21, 2019
MAKO 7
HIH
Hysteroscope (and Accessories)
208d
Cleared
May 17, 2019
KY Banksy Moisture
NUC
Lubricant, Personal
150d
Cleared
May 17, 2019
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
MQF
Catheter, Assisted Reproduction
30d
Cleared
May 16, 2019
Aveta System
HIH
Hysteroscope (and Accessories)
90d
Cleared
May 15, 2019
Endosee System
HIH
Hysteroscope (and Accessories)
63d
Cleared
May 10, 2019
Hysteroscope System
HIH
Hysteroscope (and Accessories)
332d
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