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

4478
Total
4465
Cleared
163d
Avg (2y)
1976
Since
849 Obstetrics & Gynecology devices
701–725 of 849
Cleared Sep 14, 2011
LITE PELVIC FLOOR REPAIR KITS
K103426 · Boston Scientific Corp
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 296d
Cleared Apr 01, 2011
ALYTE Y-MESH GRAFT
K101722 · C.R. Bard, Inc.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 287d
Cleared Mar 30, 2011
TRUCLEAR MORCELLATOR SYSTEM
K110038 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 83d
Cleared Mar 25, 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 127d
Cleared Apr 16, 2010
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
K100663 · Boston Scientific Corporation
NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 39d
Cleared Nov 10, 2009
BARD SACROCOLPOPEXY GRAFT
K090739 · C.R. Bard, Inc.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 235d
Cleared Mar 30, 2009
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 369d
Cleared Jan 15, 2009
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K083839 · C.R. Bard, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 23d
Cleared Jan 07, 2009
NEO-VAGINA SURGERY SET AND ACCESSORIES
K071754 · KARL STORZ Endoscopy-America, Inc.
HDX · Dilator, Vaginal · 559d
Cleared Sep 30, 2008
AVAULTA SUPPORT SYSTEM
K082571 · C.R. Bard, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 25d
Cleared Aug 22, 2008
PINNACLE PELVIC FLOOR REPAIR KIT II
K081048 · Boston Scientific Corp
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 130d
Cleared Feb 08, 2008
MEDLINE DISPOSABLE VAGINAL SPECULUM
K072942 · Medline Industries, Inc.
HIB · Speculum, Vaginal, Nonmetal · 114d
Cleared Nov 08, 2007
PINNACLE PELVIC FLOOR REPAIR KITS
K071957 · Boston Scientific Corp
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 115d
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 Oct 07, 2004
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 98d
Cleared Feb 27, 2004
TRANSVAGINAL ENDOSCOPY SET
K033728 · KARL STORZ Endoscopy-America, Inc.
HEW · Culdoscope (and Accessories) · 91d
Cleared Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 175d
Cleared Sep 23, 2003
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
K030966 · Boston Scientific Corp
NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 180d
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 57d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806 · KARL STORZ Endoscopy-America, Inc.
HIG · Insufflator, Hysteroscopic · 262d
Cleared Aug 22, 2000
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K001740 · KARL STORZ Endoscopy-America, Inc.
HIH · Hysteroscope (and Accessories) · 75d
Cleared Apr 21, 2000
KSEA CHARDONNES MORCELLATION KNIFE
K000212 · KARL STORZ Endoscopy-America, Inc.
KOH · Instrument, Manual, General Obstetric-gynecologic · 88d
Cleared Feb 07, 2000
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804 · KARL STORZ Endoscopy-America, Inc.
HEW · Culdoscope (and Accessories) · 90d
Cleared Apr 02, 1999
DCI ENDOSCOPE
K990004 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 88d
Cleared Feb 01, 1999
KSEA HF-SNARE
K983901 · KARL STORZ Endoscopy-America, Inc.
HIH · Hysteroscope (and Accessories) · 90d

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All categories 849 HGX Pump, Breast, Powered 128 NUC Lubricant, Personal 117 HIH Hysteroscope (and Accessories) 70 HET Laparoscope, Gynecologic (and Accessories) 59 MQL Media, Reproductive 50 HIF Insufflator, Laparoscopic 37 HEB Tampon, Menstrual, Unscented 37 HIS Condom 30 HGM System, Monitoring, Perinatal 25 LKF Cannula, Manipulator/injector, Uterine 17 MQK Labware, Assisted Reproduction 17 MQF Catheter, Assisted Reproduction 16 HIG Insufflator, Hysteroscopic 15 KNG Monitor, Ultrasonic, Fetal 13 KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories) 11