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
3151 Obstetrics & Gynecology devices
1126–1150 of 3151
Cleared Aug 17, 2012
NEBULAE I
K120151 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 212d
Cleared Aug 03, 2012
SHANGRING
K121789 · Wuhu Snna Medical Treatment Appliance Technology C
HFX · Clamp, Circumcision · 45d
Cleared Jul 20, 2012
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
K121612 · American Medical Systems
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 49d
Cleared Jul 19, 2012
CONTINUOUS SINGLE CULTURE COMPLETE
K121572 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 51d
Cleared Jul 19, 2012
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
K121868 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 23d
Cleared Jul 18, 2012
INSUFLOW SYNERGY PORT
K120640 · Lexion Medical, LLC
HIF · Insufflator, Laparoscopic · 138d
Cleared Jul 13, 2012
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
K111014 · Lsi Solutions, Inc.
HEW · Culdoscope (and Accessories) · 459d
Cleared Jul 13, 2012
MONICA AN24
K112390 · Monica Healthcare, Ltd.
OSP · Uterine Electromyographic Monitor · 330d
Cleared Jul 13, 2012
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
K112413 · Research Instruments , Ltd.
MQK · Labware, Assisted Reproduction · 326d
Cleared Jul 13, 2012
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
K120481 · Tosama, D.O.O.
HEB · Tampon, Menstrual, Unscented · 148d
Cleared Jul 11, 2012
POISE PERSONAL LUBRICANT
K120650 · Kimberly Clark Corporation
NUC · Lubricant, Personal · 131d
Cleared Jul 03, 2012
ORANGE COLORED CONDOMS ORANGE SCENT
K113056 · Karex Industries Sdn. Bhd.
HIS · Condom · 263d
Cleared Jul 03, 2012
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
K121336 · Surgiquest, Inc.
HIF · Insufflator, Laparoscopic · 61d
Cleared Jun 29, 2012
TUBALGATOR
K113080 · Mectra Labs, Inc.
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 255d
Cleared Jun 22, 2012
CARBONAID C02 DIFFUSER
K112975 · Cardia Innovation AB
HIF · Insufflator, Laparoscopic · 261d
Cleared Jun 21, 2012
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
K120245 · Playtex, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 146d
Cleared Jun 20, 2012
MICROMANIPULATOR SET
K120877 · Narishige Co., Ltd.
MQJ · Micromanipulators And Microinjectors, Assisted Reproduction · 89d
Cleared Jun 19, 2012
TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
K120286 · Church & Dwight Co., Inc.
HIS · Condom · 140d
Cleared Jun 18, 2012
MATRIXBRUSH ENDOMETRIAL SAMPLER
K112763 · Post Oak Innovations, Inc.
HFE · Brush, Endometrial · 270d
Cleared Jun 14, 2012
OBIX PERINATAL DATA SYSTEM 7.0
K121208 · Clinical Computer Systems, Inc.
HGM · System, Monitoring, Perinatal · 55d
Cleared Jun 11, 2012
ARTISYN Y-SHAPED MESH
K113205 · Ethicon, Inc.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 224d
Cleared Jun 06, 2012
MULTIPURPOSE HANDLING MEDIUM
K121128 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 54d
Cleared May 31, 2012
CLOSER TO NATURE
K121322 · Mayborn Group Limited
HGX · Pump, Breast, Powered · 29d
Cleared May 24, 2012
RHEA CUP
K112165 · Apex Medical Technologies, Inc.
HHE · Cup, Menstrual · 301d
Cleared May 17, 2012
RESTORELLE POLYPROPYLENE Y MESH
K112322 · Coloplast A/S
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 279d

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All categories 3151 NUC Lubricant, Personal 228 HET Laparoscope, Gynecologic (and Accessories) 224 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 206 HIS Condom 196 HEB Tampon, Menstrual, Unscented 155 HGM System, Monitoring, Perinatal 154 HIH Hysteroscope (and Accessories) 143 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 MQK Labware, Assisted Reproduction 43 HIG Insufflator, Hysteroscopic 43