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
1901–1925 of 4525
Cleared Nov 28, 2001
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
K012917 · Dynarex Corp.
HFW · Clamp, Umbilical · 90d
Cleared Nov 27, 2001
ORALLITE COMPREHENSIVE EXAM TRAY
K012070 · Trylon Corp.
MPU · Source, Chemiluminescent Light · 148d
Cleared Nov 19, 2001
SF SH CATHETER, MODEL R65-945
K013437 · A & A Medical, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 33d
Cleared Nov 19, 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491 · A & A Medical, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 28d
Cleared Nov 13, 2001
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
K012718 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 90d
Cleared Nov 09, 2001
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012664 · Innolatex Sdn. Bhd
HIS · Condom · 88d
Cleared Nov 09, 2001
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
K012665 · Innolatex Sdn. Bhd
HIS · Condom · 88d
Cleared Nov 09, 2001
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
K012962 · Innolatex Sdn. Bhd
HIS · Condom · 66d
Cleared Nov 09, 2001
56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
K012964 · Innolatex Sdn. Bhd
HIS · Condom · 66d
Cleared Nov 09, 2001
FAS SET #4551
K013497 · Gynetics Medical Products NV
MQE · Needle, Assisted Reproduction · 18d
Cleared Oct 26, 2001
NU-SPEC D
K012859 · Sol Weiss MD, Inc.
HIB · Speculum, Vaginal, Nonmetal · 63d
Cleared Oct 24, 2001
EZ-ON CONDOM
K001974 · Mayer Laboratories
MOL · Condom, Synthetic · 482d
Cleared Oct 23, 2001
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 288d
Cleared Oct 11, 2001
THECURVE, ITEM 507
K012935 · Select Medical Systems, Inc.
MFD · Cannula, Intrauterine Insemination · 41d
Cleared Oct 05, 2001
ALWAYS DUETS
K012629 · Procter & Gamble Co.
HHD · Pad, Menstrual, Unscented · 53d
Cleared Sep 21, 2001
MALE LATEX CONDOM
K012653 · Qingdao Shuang Die Latex Production Co.,Ltd
HIS · Condom · 39d
Cleared Sep 19, 2001
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
K011996 · Procter & Gamble Co.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 84d
Cleared Aug 27, 2001
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
K002328 · Richard Wolf Medical Instruments Corp.
HIF · Insufflator, Laparoscopic · 391d
Cleared Aug 27, 2001
CLAY-PARK LABS, INC. - LUBRICATING JELLY
K012203 · Clay-Park Labs, Inc.
NUC · Lubricant, Personal · 45d
Cleared Aug 27, 2001
TAO EMBRYO TRANSFER CATHETER SYSTEM
K012220 · Ttj Biomedical, LLC
MQF · Catheter, Assisted Reproduction · 42d
Cleared Aug 16, 2001
AQUASENS FLUID MONITORING SYSTEM
K011069 · Davol Inc., Sub. C. R. Bard, Inc.
HIG · Insufflator, Hysteroscopic · 129d
Cleared Aug 15, 2001
AMEDA HYGIENIKIT
K011519 · Hollister, Inc.
HGY · Pump, Breast, Non-powered · 90d
Cleared Aug 10, 2001
SPERMCATCH
K011607 · Nidacon International AB
MQL · Media, Reproductive · 78d
Cleared Aug 10, 2001
KOALA CLAMP, KOALA CLAMP AND CUTTER
K011621 · Maternus, Inc.
HFW · Clamp, Umbilical · 77d
Cleared Aug 10, 2001
CERVILENZ UTERINE MEASURING SOUND
K011840 · Cervilenz, Inc.
HHM · Sound, Uterine · 59d

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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