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
Nov 18, 2011
HIGH FLOW INSUFFLATION UNIT UHI-4
HIF
Insufflator, Laparoscopic
290d
Cleared
Nov 16, 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
HIF
Insufflator, Laparoscopic
128d
Cleared
Nov 10, 2011
VESSEL GUARDIAN
HIF
Insufflator, Laparoscopic
86d
Cleared
Nov 08, 2011
FM20
HGM
System, Monitoring, Perinatal
250d
Cleared
Nov 02, 2011
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
HEB
Tampon, Menstrual, Unscented
21d
Cleared
Oct 25, 2011
AMS ELEVATE PC
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
26d
Cleared
Oct 12, 2011
FEMCHEC PRESSURE MANAGEMET DEVICE
LKF
Cannula, Manipulator/injector, Uterine
187d
Cleared
Oct 07, 2011
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
HEB
Tampon, Menstrual, Unscented
28d
Cleared
Oct 05, 2011
SINGHMED ROOLIP MANIPULATOR
HEW
Culdoscope (and Accessories)
196d
Cleared
Sep 26, 2011
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
HGM
System, Monitoring, Perinatal
110d
Cleared
Sep 21, 2011
CMS-1000FM CENTRAL MONITORING SYSTEM
HGM
System, Monitoring, Perinatal
56d
Cleared
Sep 15, 2011
KOLPLUX SYSTEM
HIB
Speculum, Vaginal, Nonmetal
181d
Cleared
Sep 14, 2011
LITE PELVIC FLOOR REPAIR KITS
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
296d
Cleared
Sep 08, 2011
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
21d
Cleared
Sep 01, 2011
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
HIN
Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
136d
Cleared
Aug 30, 2011
MONICA IF24
OSP
Uterine Electromyographic Monitor
34d
Cleared
Aug 19, 2011
UNIMAX VERESS NEEDLE
HIF
Insufflator, Laparoscopic
87d
Cleared
Aug 17, 2011
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
HGM
System, Monitoring, Perinatal
120d
Cleared
Aug 11, 2011
LUCINA MODEL MELODI
HGX
Pump, Breast, Powered
343d
Cleared
Aug 11, 2011
EEVATM PETRI DISH
MQK
Labware, Assisted Reproduction
302d
Cleared
Aug 11, 2011
EMBRYOSCOPE
MQG
Accessory, Assisted Reproduction
52d
Cleared
Jul 19, 2011
MINI TELEMETRY SYSTEM
HGM
System, Monitoring, Perinatal
141d
Cleared
Jul 19, 2011
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
HIG
Insufflator, Hysteroscopic
113d
Cleared
Jul 07, 2011
SURELIFT PROLAPSE SYSTEM
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
282d
Cleared
Jul 01, 2011
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
71d
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