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

4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3156 Obstetrics & Gynecology devices
1626–1650 of 3156
Cleared Feb 08, 2001
ENVIVE MINIFORMS
K003843 · Procter & Gamble Co.
HHD · Pad, Menstrual, Unscented · 58d
Cleared Feb 01, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
K010056 · A & A Medical, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 24d
Cleared Jan 17, 2001
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
K003278 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 90d
Cleared Jan 08, 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared Dec 28, 2000
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
K001576 · Prosurg, Inc.
NBV · Device, Engorgement, Clitoral · 220d
Cleared Dec 07, 2000
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 31d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806 · KARL STORZ Endoscopy-America, Inc.
HIG · Insufflator, Hysteroscopic · 262d
Cleared Nov 22, 2000
CODA INCUBATOR CELLMATE
K001600 · Intl., Inc.
MQG · Accessory, Assisted Reproduction · 182d
Cleared Nov 22, 2000
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K003300 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 33d
Cleared Nov 22, 2000
IM-5A INJECTOR
K003302 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 33d
Cleared Nov 22, 2000
IM-5B MICROINJECTOR
K003303 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 33d
Cleared Nov 22, 2000
IM-6 MICROINJECTOR
K003304 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 33d
Cleared Nov 21, 2000
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
K003298 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 32d
Cleared Nov 09, 2000
FETALGARD LITE
K002503 · Analogic Corp.
HGM · System, Monitoring, Perinatal · 87d
Cleared Nov 06, 2000
VIPON TAMPON
K992493 · Another Way Products, LLC
HEB · Tampon, Menstrual, Unscented · 469d
Cleared Oct 30, 2000
PBN FALLOPIAN TUBE CATHETER SYSTEM
K000620 · Medical Device Technologies, Inc.
MDG · System, Intrafallopian Cannula · 249d
Cleared Oct 13, 2000
BVI SLING
K002233 · Bio-Vascular, Inc.
PAJ · Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 81d
Cleared Oct 05, 2000
MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
K002850 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 22d
Cleared Sep 29, 2000
BIOSYS FETAL MONITOR, MODEL IFM-500
K994008 · Biosys Co. , Ltd.
HGM · System, Monitoring, Perinatal · 310d
Cleared Sep 22, 2000
MMN-1 COARSE MANIPULATOR
K002653 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 28d
Cleared Sep 22, 2000
MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR
K002658 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 28d
Cleared Sep 22, 2000
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
K002659 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 28d
Cleared Sep 18, 2000
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
K002385 · Cook Ob/Gyn
MQL · Media, Reproductive · 45d
Cleared Sep 15, 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc.
MQG · Accessory, Assisted Reproduction · 126d
Cleared Sep 13, 2000
MOTOR-DRIVE MANIPULATOR MM-89
K002291 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 48d

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All categories 3156 NUC Lubricant, Personal 228 HET Laparoscope, Gynecologic (and Accessories) 225 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 206 HIS Condom 196 HEB Tampon, Menstrual, Unscented 155 HGM System, Monitoring, Perinatal 155 HIH Hysteroscope (and Accessories) 144 HIF Insufflator, Laparoscopic 131 HIL Tampon, Menstrual, Scented, Scented-deodorized 75 HHD Pad, Menstrual, Unscented 64 LKF Cannula, Manipulator/injector, Uterine 61 HHL Pad, Menstrual, Scented, Scented-deodorized 45 HIG Insufflator, Hysteroscopic 43 MQK Labware, Assisted Reproduction 43