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
726–750 of 1727
Cleared Apr 11, 2014
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
K134047 · Integra LifeSciences Corporation
HCZ · Forceps, Surgical, Gynecological · 101d
Cleared Feb 12, 2014
RESTORELLE Y CONTOUR MESH
K140116 · Coloplast A/S
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 27d
Cleared Dec 13, 2013
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
K132015 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 165d
Cleared Sep 27, 2013
COOK CERVICAL RIPENING BALLOON
K131206 · Cook, Inc.
PFJ · Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor · 151d
Cleared Sep 27, 2013
MORCELLEX SIGMA GENERATOR
K131656 · Ethicon, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 113d
Cleared Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
K131581 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 83d
Cleared Aug 22, 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
K131736 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 70d
Cleared Aug 02, 2013
RESTORELLE M, RESTORELLE XL
K132061 · Coloplast Corp.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 30d
Cleared Jun 26, 2013
KSEA BIPOLAR ELECTRODE
K122983 · KARL STORZ Endoscopy-America, Inc.
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 273d
Cleared Jun 07, 2013
BEARING NSPVA EMBOLIZATION PARTICLES
K130259 · Merit Medical Systems, Inc.
NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 126d
Cleared Mar 05, 2013
RESTORELLE Y CONTOUR
K123914 · Coloplast A/S
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 76d
Cleared Mar 01, 2013
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
K123365 · Olympus Medical Systems Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 121d
Cleared Dec 18, 2012
UPSYLON Y MESH
K122794 · Boston Scientific Corp
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 97d
Cleared Dec 18, 2012
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
K122968 · Coloplast Corp.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 84d
Cleared Dec 13, 2012
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
K122459 · Boston Scientific Corporation
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 122d
Cleared Dec 05, 2012
PKS BILL
K122605 · Gyrus Acmi, Inc.
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 100d
Cleared Nov 19, 2012
RESTORELLE L
K122440 · Coloplast Corp.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 101d
Cleared Nov 13, 2012
HIGH FLOW INSUFFLANTION UNIT
K122180 · Olympus Medical Systems Corporation
HIF · Insufflator, Laparoscopic · 113d
Cleared Oct 26, 2012
SPERMFREEZE SOLUTION
K113786 · Vitrolife Sweden AB
MQL · Media, Reproductive · 309d
Cleared Sep 19, 2012
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
K122563 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 28d
Cleared Sep 10, 2012
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
K122498 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 25d
Cleared Aug 17, 2012
NEBULAE I
K120151 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 212d
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 Jun 11, 2012
ARTISYN Y-SHAPED MESH
K113205 · Ethicon, Inc.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 224d

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All categories 1727 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 MQL Media, Reproductive 121 NUC Lubricant, Personal 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