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
Aug 06, 2013
OVUSENSE
LHD
Device, Fertility Diagnostic, Proceptive
369d
Cleared
Aug 06, 2013
CLEARSPEC SINGLE USE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
210d
Cleared
Aug 02, 2013
RESTORELLE M, RESTORELLE XL
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
30d
Cleared
Aug 01, 2013
AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
NUC
Lubricant, Personal
171d
Cleared
Jul 29, 2013
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
PBQ
Fixation, Non-absorbable Or Absorbable, For Pelvic Use
200d
Cleared
Jul 24, 2013
LINA BIPOLAR LOOP
HIN
Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
169d
Cleared
Jul 03, 2013
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
MQK
Labware, Assisted Reproduction
219d
Cleared
Jun 28, 2013
NIRVANA D PERSONAL LUBRICANT (TBD)
NUC
Lubricant, Personal
233d
Cleared
Jun 28, 2013
SURECALL LABOR MONITOR
OSP
Uterine Electromyographic Monitor
177d
Cleared
Jun 26, 2013
KSEA BIPOLAR ELECTRODE
HIN
Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
273d
Cleared
Jun 25, 2013
SHANGRING
HFX
Clamp, Circumcision
43d
Cleared
Jun 20, 2013
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
HEB
Tampon, Menstrual, Unscented
22d
Cleared
Jun 18, 2013
VIKY UP
LKF
Cannula, Manipulator/injector, Uterine
277d
Cleared
Jun 18, 2013
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
55d
Cleared
Jun 14, 2013
MODULAP LOOP
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
406d
Cleared
Jun 12, 2013
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
HEX
Colposcope (and Colpomicroscope)
259d
Cleared
Jun 07, 2013
BEARING NSPVA EMBOLIZATION PARTICLES
NAJ
Agents, Embolic, For Treatment Of Uterine Fibroids
126d
Cleared
May 30, 2013
MEMORY PUMP MODEL Y4947
HGX
Pump, Breast, Powered
48d
Cleared
Apr 25, 2013
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
209d
Cleared
Apr 09, 2013
WARMING JELLY PERSONAL LUBRICANT
NUC
Lubricant, Personal
123d
Cleared
Apr 05, 2013
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
322d
Cleared
Apr 05, 2013
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
PAI
Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
93d
Cleared
Apr 04, 2013
HYSTEROSCOPY PUMP HM6
HIG
Insufflator, Hysteroscopic
120d
Cleared
Mar 21, 2013
SUNRAY FETAL MONITOR
HGM
System, Monitoring, Perinatal
146d
Cleared
Mar 21, 2013
VEEDA 100% COTTON MENSTRUAL TAMPON
HEB
Tampon, Menstrual, Unscented
14d
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