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
926–950 of 1727
Cleared Dec 07, 2000
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 31d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806 · KARL STORZ Endoscopy-America, Inc.
HIG · Insufflator, Hysteroscopic · 262d
Cleared Oct 30, 2000
PBN FALLOPIAN TUBE CATHETER SYSTEM
K000620 · Medical Device Technologies, Inc.
MDG · System, Intrafallopian Cannula · 249d
Cleared Sep 18, 2000
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
K002385 · Cook Ob/Gyn
MQL · Media, Reproductive · 45d
Cleared Sep 13, 2000
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
K002383 · Cook Ob/Gyn
MQL · Media, Reproductive · 40d
Cleared Aug 22, 2000
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K001740 · KARL STORZ Endoscopy-America, Inc.
HIH · Hysteroscope (and Accessories) · 75d
Cleared Jun 16, 2000
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
K000433 · Medical Device Technologies, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 128d
Cleared Jun 09, 2000
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · Xomed, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 224d
Cleared May 26, 2000
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
K000673 · Richard Wolf Medical Instruments Corp.
HIH · Hysteroscope (and Accessories) · 88d
Cleared May 23, 2000
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974 · Utah Medical Products, Inc.
HHK · Curette, Suction, Endometrial (and Accessories) · 57d
Cleared May 17, 2000
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
K991348 · Vitrolife Sweden AB
MQL · Media, Reproductive · 394d
Cleared May 16, 2000
ENDOPATH SURESEAL REDUCER CAP
K001220 · Ethicon Endo-Surgery, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 29d
Cleared May 09, 2000
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC
HIS · Condom · 25d
Cleared Apr 21, 2000
KSEA CHARDONNES MORCELLATION KNIFE
K000212 · KARL STORZ Endoscopy-America, Inc.
KOH · Instrument, Manual, General Obstetric-gynecologic · 88d
Cleared Apr 06, 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC
HIS · Condom · 29d
Cleared Mar 13, 2000
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
K000309 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 41d
Cleared Mar 01, 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · Cook Urological, Inc.
MQE · Needle, Assisted Reproduction · 63d
Cleared Feb 25, 2000
OVOIL-150, MODEL 5002
K991351 · Vitrolife Sweden AB
MQL · Media, Reproductive · 312d
Cleared Feb 24, 2000
PH-100, MODEL 2104
K991346 · Vitrolife Sweden AB
MQL · Media, Reproductive · 311d
Cleared Feb 18, 2000
ASP-100, MODEL 2100
K991345 · Vitrolife Sweden AB
MQL · Media, Reproductive · 305d
Cleared Feb 07, 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801 · Ethicon, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared Feb 07, 2000
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804 · KARL STORZ Endoscopy-America, Inc.
HEW · Culdoscope (and Accessories) · 90d
Cleared Feb 02, 2000
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 89d
Cleared Jan 24, 2000
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K994418 · Ethicon, Inc.
HIH · Hysteroscope (and Accessories) · 26d
Cleared Dec 13, 1999
MENTOR EVACARE VAGINAL PESSARIES
K993308 · Mentor Corp.
HHW · Pessary, Vaginal · 70d

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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