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

4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
1626–1650 of 4525
Cleared Nov 22, 2004
MEDICULT IVM SYSTEM
K041284 · Medicult A/S
MQL · Media, Reproductive · 193d
Cleared Nov 22, 2004
MORTON IUI CATHETERS
K041470 · Fertility Technology Resources, Inc.
MQF · Catheter, Assisted Reproduction · 173d
Cleared Nov 17, 2004
MINIMESH POLYPROPYLENE MESH
K041632 · Mpathy Medical Devices, Ltd.
OTO · Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · 154d
Cleared Nov 08, 2004
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
K042527 · Medical Action Industries, Inc.
HHT · Spatula, Cervical, Cytological · 52d
Not Cleared Nov 04, 2004
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
DEN040009 · Hamilton Thorne Biosciences
MRX · System, Assisted Reproduction Laser · 71d
Cleared Oct 18, 2004
DRG SOFTRELEASE
K041018 · Doctor'S Research Group, Inc.
HHT · Spatula, Cervical, Cytological · 181d
Cleared Oct 07, 2004
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 98d
Cleared Oct 04, 2004
ENDOMETRIAL SAMPLING SYRINGE
K040189 · Rocket Medical Plc
HHK · Curette, Suction, Endometrial (and Accessories) · 250d
Cleared Oct 01, 2004
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · Cook Urological, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 161d
Cleared Sep 29, 2004
THE STRIPPER PGD
K041435 · Mid-Atlantic Diagnostics, Inc.
MQH · Microtools, Assisted Reproduction (pipettes) · 124d
Cleared Sep 28, 2004
FLO-ASSISTANT
K041560 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 110d
Cleared Sep 24, 2004
PERSONAL LUBRICATING GEL
K041129 · Qualis, Inc.
NUC · Lubricant, Personal · 147d
Cleared Sep 24, 2004
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
K041837 · Innolatex Sdn. Bhd
HIS · Condom · 79d
Cleared Sep 14, 2004
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K040392 · American I.V. Products, Inc.
HFM · Monitor, Uterine Contraction, External (for Use In Clinic) · 210d
Cleared Sep 08, 2004
ECHOSAMPLER
K041237 · Gynetics Medical Products NV
HFF · Aspirator, Endometrial · 120d
Cleared Sep 02, 2004
CADENCE, MODELS 2001 AND 2002
K040903 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 148d
Cleared Aug 16, 2004
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
K040819 · American I.V. Products, Inc.
HGM · System, Monitoring, Perinatal · 139d
Cleared Aug 12, 2004
NUNC IVF MULTIDISH 4 WELLS NUNCLON
K040717 · Nunc A/S
MQK · Labware, Assisted Reproduction · 146d
Cleared Aug 09, 2004
CRYOTIP
K041562 · Irvine Scientific Sales Co., Inc.
MQH · Microtools, Assisted Reproduction (pipettes) · 60d
Cleared Jul 29, 2004
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
K033614 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 255d
Cleared Jul 09, 2004
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K040999 · Procter & Gamble Co.
HEB · Tampon, Menstrual, Unscented · 81d
Cleared Jul 09, 2004
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
K041321 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 52d
Cleared Jun 25, 2004
INSTEAD INTIMATE LUBRICANT
K033776 · Instead, Inc.
NUC · Lubricant, Personal · 205d
Cleared Jun 25, 2004
MEDIA CULTURE SYSTEM
K040530 · Intl., Inc.
MQL · Media, Reproductive · 116d
Cleared Jun 25, 2004
JOEY CLAMP OPENING TOOL
K041332 · Maternus, Inc.
HFW · Clamp, Umbilical · 37d

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All categories 4525 HIS Condom 401 HET Laparoscope, Gynecologic (and Accessories) 335 MQL Media, Reproductive 259 HGX Pump, Breast, Powered 254 NUC Lubricant, Personal 249 HGM System, Monitoring, Perinatal 209 HEB Tampon, Menstrual, Unscented 189 HIF Insufflator, Laparoscopic 177 HIH Hysteroscope (and Accessories) 173 HHD Pad, Menstrual, Unscented 136 LKF Cannula, Manipulator/injector, Uterine 87 HIL Tampon, Menstrual, Scented, Scented-deodorized 84 HIB Speculum, Vaginal, Nonmetal 72 HHT Spatula, Cervical, Cytological 70 KNA Instrument, Manual, Specialized Obstetric-gynecologic 58