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
751–775 of 1727
Cleared Jun 06, 2012
MULTIPURPOSE HANDLING MEDIUM
K121128 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 54d
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
Cleared Apr 20, 2012
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
K111425 · Olympus Medical Systems Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 333d
Cleared Mar 23, 2012
MYOSURE CONTROL UNIT
K120593 · Hologic, Inc.
HIH · Hysteroscope (and Accessories) · 24d
Cleared Mar 23, 2012
SPECULUM, VAGINAL, NONMETAL
K120743 · Welch Allyn, Inc.
HIB · Speculum, Vaginal, Nonmetal · 11d
Cleared Feb 08, 2012
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
K103726 · Integra LifeSciences Corporation
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 413d
Cleared Jan 13, 2012
ENDOEYE HD II
K111788 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 203d
Cleared Dec 02, 2011
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
K111751 · Ethicon, Inc.
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 163d
Cleared Nov 22, 2011
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 118d
Cleared Nov 18, 2011
HIGH FLOW INSUFFLATION UNIT UHI-4
K110294 · Olympus Medical Systems Corporation
HIF · Insufflator, Laparoscopic · 290d
Cleared Nov 16, 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · Medline Industries, Inc.
HIF · Insufflator, Laparoscopic · 128d
Cleared Oct 25, 2011
AMS ELEVATE PC
K112842 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 26d
Cleared Oct 07, 2011
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K112635 · Kimberly-Clark Corp.
HEB · Tampon, Menstrual, Unscented · 28d
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 Sep 08, 2011
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
K112386 · Coloplast Corp.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 21d
Cleared Sep 01, 2011
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
K111059 · Gyrus Acmi, Inc.
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 136d
Cleared Jul 19, 2011
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K110852 · Gyrus Acmi, Inc.
HIG · Insufflator, Hysteroscopic · 113d
Cleared May 06, 2011
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
K102141 · Cook Urological, Inc.
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 281d
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 Jan 13, 2011
FETAL MONITORS, MODELS F2 AND F3
K102140 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 168d
Cleared Jan 11, 2011
BT-CATH
K101535 · Utah Medical Products, Inc.
OQY · Intrauterine Tamponade Balloon · 222d
Cleared Jan 06, 2011
CENTRAL MONITORING SYSTEM
K100358 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 328d
Cleared Dec 10, 2010
RAPIDVIT BLAST, RAPIDWARM BLAST
K101003 · Vitrolife Sweden AB
MQL · Media, Reproductive · 242d

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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