FDA Review Panel · OB

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
1476–1500 of 4525
Cleared Apr 24, 2007
ZILOS-TK
K063636 · Hamilton Thorne Biosciences
MRX · System, Assisted Reproduction Laser · 138d
Cleared Apr 13, 2007
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
K070745 · Playtex Products, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 25d
Cleared Apr 04, 2007
CVS PERSONAL LUBRICANT AND MOISTURIZER
K062682 · Lake Consumer Products, Inc.
NUC · Lubricant, Personal · 208d
Cleared Mar 26, 2007
BANANA RIBBED
K063401 · Medtech Products , Ltd.
HIS · Condom · 137d
Cleared Mar 23, 2007
K-Y BRAND WARMING LIQUID
K070545 · Personal Products Co.
NUC · Lubricant, Personal · 25d
Cleared Mar 16, 2007
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
K062433 · Diamics, Inc.
HHT · Spatula, Cervical, Cytological · 207d
Cleared Mar 14, 2007
CONCEIVEX CONCEPTION KIT
K063227 · Conceivex, Inc.
OBB · Kit, Conception-assist, Home Use · 141d
Cleared Mar 12, 2007
SATURN 3 LASER SYSTEM
K060764 · Research Instruments , Ltd.
MRX · System, Assisted Reproduction Laser · 356d
Cleared Mar 12, 2007
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K063712 · C.R. Bard, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 88d
Cleared Feb 26, 2007
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
K063562 · Ethicon, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 91d
Cleared Feb 08, 2007
EMBRYOASSIST
K061309 · Medicult A/S
MQL · Media, Reproductive · 274d
Not Cleared Jan 30, 2007
COMPUTERIZED LABOR MONITORING SYSTEM
DEN060006 · Barnev, Ltd.
NPB · System, Monitoring, For Progress Of Labor · 104d
Cleared Jan 26, 2007
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
K062535 · Mcneil-Ppc, Inc.
NUC · Lubricant, Personal · 150d
Cleared Jan 17, 2007
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
K063429 · Generic Medical Device, Inc.
HFX · Clamp, Circumcision · 65d
Cleared Jan 10, 2007
INSUFLOW DEVICE, MODEL 6198
K063546 · Lexion Medical, LLC
HIF · Insufflator, Laparoscopic · 47d
Cleared Dec 26, 2006
MOONCUP
K060852 · Mooncup Limited
HHE · Cup, Menstrual · 273d
Cleared Dec 15, 2006
OCTAX LASER SHOT SYSTEM
K062524 · Minitube of America, Inc.
MRX · System, Assisted Reproduction Laser · 109d
Cleared Dec 08, 2006
K-Y BRAND INTRIGUE
K062796 · Personal Products Co.
NUC · Lubricant, Personal · 80d
Cleared Dec 07, 2006
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
K062001 · Rostam , Ltd.
HEB · Tampon, Menstrual, Unscented · 146d
Cleared Dec 04, 2006
INTIMOL
K061466 · Dlc Laboratories, Inc.
NUC · Lubricant, Personal · 192d
Cleared Nov 22, 2006
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
K062638 · Procter & Gamble Co.
HEB · Tampon, Menstrual, Unscented · 78d
Cleared Oct 27, 2006
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
K062438 · Cook Ob/Gyn
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 67d
Cleared Oct 20, 2006
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
K061651 · Apple Medical Corp.
HGI · Electrocautery, Gynecologic (and Accessories) · 129d
Cleared Oct 13, 2006
PRE' VAGINAL LUBRICANT
K051436 · Ingfertlity, LLC
PEB · Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible · 499d
Cleared Oct 13, 2006
WALLACE ARTIFICIAL INSEMINATION CATHETER
K061679 · Irvine Scientific Sales Co., Inc.
LKF · Cannula, Manipulator/injector, Uterine · 120d

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All categories 4525 HIS Condom 401 HET Laparoscope, Gynecologic (and Accessories) 335 MQL Media, Reproductive 259 HGX Pump, Breast, Powered 254 NUC Lubricant, Personal 249 HGM System, Monitoring, Perinatal 209 HEB Tampon, Menstrual, Unscented 189 HIF Insufflator, Laparoscopic 177 HIH Hysteroscope (and Accessories) 173 HHD Pad, Menstrual, Unscented 136 LKF Cannula, Manipulator/injector, Uterine 87 HIL Tampon, Menstrual, Scented, Scented-deodorized 84 HIB Speculum, Vaginal, Nonmetal 72 HHT Spatula, Cervical, Cytological 70 KNA Instrument, Manual, Specialized Obstetric-gynecologic 58