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

4499
Total
4485
Cleared
168d
Avg (2y)
1976
Since
1727 Obstetrics & Gynecology devices
826–850 of 1727
Cleared May 18, 2007
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
K070964 · Welch Allyn, Inc.
HIB · Speculum, Vaginal, Nonmetal · 43d
Cleared Mar 23, 2007
K-Y BRAND WARMING LIQUID
K070545 · Personal Products Co.
NUC · Lubricant, Personal · 25d
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 Dec 08, 2006
K-Y BRAND INTRIGUE
K062796 · Personal Products Co.
NUC · Lubricant, Personal · 80d
Cleared Oct 27, 2006
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
K062438 · Cook Ob/Gyn
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 67d
Cleared Oct 13, 2006
WALLACE ARTIFICIAL INSEMINATION CATHETER
K061679 · Irvine Scientific Sales Co., Inc.
LKF · Cannula, Manipulator/injector, Uterine · 120d
Cleared Oct 13, 2006
VERESS CANNULA AND MODULAR VERESS CANNULA
K062097 · PAJUNK GmbH Medizintechnologie
HET · Laparoscope, Gynecologic (and Accessories) · 81d
Cleared Aug 24, 2006
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
K062169 · Applied Medical Resources Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 24d
Cleared Aug 17, 2006
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · Cook Urological, Inc.
MQL · Media, Reproductive · 92d
Cleared Jul 14, 2006
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
K061050 · Ethicon, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 88d
Cleared Jun 29, 2006
SONOHYSTEROGRAPHY BIOPSY DEVICE
K060908 · Cook Urological, Inc.
PGK · Cannula, Injector, Uterine, Endometrial Biopsy · 87d
Cleared Apr 24, 2006
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
K060168 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 91d
Cleared Dec 30, 2005
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
K052795 · Philips Medizin Systeme Boeblingen GmbH
HGM · System, Monitoring, Perinatal · 88d
Cleared Dec 27, 2005
MENTOR NOVASILK MESH
K053414 · Mentor Corp.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 20d
Cleared Aug 05, 2005
UGYTEX SUAL KNIT MESH
K051503 · Sofradim Production
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 59d
Cleared Aug 03, 2005
AMS PELVIC FLOOR REPAIR SYSTEM
K051485 · American Medical Systems, Inc.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 58d
Cleared Jun 21, 2005
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K050583 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 106d
Cleared Apr 21, 2005
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K050404 · Intuitive Surgical, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 63d
Cleared Mar 31, 2005
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
K050639 · Lumenis, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 17d
Cleared Jan 13, 2005
ICSI-100
K043116 · Vitrolife Sweden AB
MQL · Media, Reproductive · 64d
Cleared Dec 22, 2004
GYNECARE PROLENE FASTENER SYSTEM
K042603 · Ethicon, Inc.
PBQ · Fixation, Non-absorbable Or Absorbable, For Pelvic Use · 89d
Cleared Oct 07, 2004
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 98d
Cleared Oct 01, 2004
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · Cook Urological, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 161d
Cleared Sep 28, 2004
FLO-ASSISTANT
K041560 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 110d

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All categories 1727 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 NUC Lubricant, Personal 121 MQL Media, Reproductive 121 HIH Hysteroscope (and Accessories) 106 HEB Tampon, Menstrual, Unscented 100 HGM System, Monitoring, Perinatal 86 HIF Insufflator, Laparoscopic 80 HHD Pad, Menstrual, Unscented 54 LKF Cannula, Manipulator/injector, Uterine 43 HHL Pad, Menstrual, Scented, Scented-deodorized 38 HIS Condom 37 HIG Insufflator, Hysteroscopic 27 HIL Tampon, Menstrual, Scented, Scented-deodorized 24 MQF Catheter, Assisted Reproduction 24