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
1501–1525 of 4525
Cleared Oct 13, 2006
VERESS CANNULA AND MODULAR VERESS CANNULA
K062097 · PAJUNK GmbH Medizintechnologie
HET · Laparoscope, Gynecologic (and Accessories) · 81d
Cleared Oct 06, 2006
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
K050197 · Minitube of America, Inc.
MQG · Accessory, Assisted Reproduction · 617d
Cleared Oct 05, 2006
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
K062730 · Biogreen Medical Sdn. Bhd.
HIS · Condom · 22d
Cleared Oct 02, 2006
SPERMSLOW
K061145 · Medicult A/S
MQL · Media, Reproductive · 160d
Cleared Sep 19, 2006
HIERSPEC SPECULUM
K061339 · Medical Products Div.
HIB · Speculum, Vaginal, Nonmetal · 127d
Cleared Sep 12, 2006
ZEUS MALE CONDOM APPLICATOR
K052206 · Condax, LLC
HIS · Condom · 396d
Cleared Aug 24, 2006
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
K062169 · Applied Medical Resources Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 24d
Cleared Aug 17, 2006
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · Cook Urological, Inc.
MQL · Media, Reproductive · 92d
Cleared Aug 15, 2006
PLAYTEX EMBRACE PETITE BREAST PUMP
K061013 · Playtex Products, Inc.
HGX · Pump, Breast, Powered · 124d
Cleared Aug 07, 2006
CO-1000 COLPOSCOPE, MULTIPLE
K061306 · Gynex Corp.
HEX · Colposcope (and Colpomicroscope) · 89d
Cleared Aug 01, 2006
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
K061486 · Procter & Gamble Co.
HEB · Tampon, Menstrual, Unscented · 62d
Cleared Jul 31, 2006
G-LIX TISSUE GRASPER
K061268 · Usgi Medical
HET · Laparoscope, Gynecologic (and Accessories) · 87d
Cleared Jul 28, 2006
FEMECC ENDOCERVICAL CURETTE
K060320 · Femspec LLC
PCF · Sampler, Endocervical · 170d
Cleared Jul 28, 2006
BIOPSY MEDIUM, MODEL REF 1062
K060983 · Medicult A/S
MQL · Media, Reproductive · 109d
Cleared Jul 21, 2006
VERESURE BELL
K061387 · Veresure, Inc.
HIF · Insufflator, Laparoscopic · 64d
Cleared Jul 14, 2006
INVITRO MATURATION MEDIA
K053646 · Sage In-Vitro Fertilization, Inc.
MQL · Media, Reproductive · 196d
Cleared Jul 14, 2006
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
K061050 · Ethicon, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 88d
Cleared Jul 12, 2006
FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
K051688 · Trimensa Pharmaceuticals
NUC · Lubricant, Personal · 384d
Cleared Jul 12, 2006
FEATHERLITE AQUA TOCODYNAMOMETER
K061044 · Ventrex, Inc.
HFM · Monitor, Uterine Contraction, External (for Use In Clinic) · 89d
Cleared Jul 07, 2006
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
K060289 · Frontline Medical
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 151d
Cleared Jun 29, 2006
SONOHYSTEROGRAPHY BIOPSY DEVICE
K060908 · Cook Urological, Inc.
PGK · Cannula, Injector, Uterine, Endometrial Biopsy · 87d
Cleared Jun 27, 2006
BOD POD
K060848 · Life Measurement, Inc.
OAC · Plethysmograph, Air Displacement For Body Composition Analysis · 91d
Cleared Jun 09, 2006
TIPI
K060526 · Contipi , Ltd.
HHW · Pessary, Vaginal · 102d
Cleared Jun 08, 2006
DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
K060098 · Ssl Americas, Inc.
NUC · Lubricant, Personal · 146d
Cleared May 25, 2006
40 L HIGH FLOW INSUFFLATOR F113
K060723 · W.O.M. World of Medicine AG
HIF · Insufflator, Laparoscopic · 69d

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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