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

4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3164 Obstetrics & Gynecology devices
2326–2350 of 3164
Cleared Nov 15, 1994
ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER
K943954 · Conmedcorp
HIF · Insufflator, Laparoscopic · 92d
Cleared Nov 03, 1994
COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES
K943776 · Richard Wolf Medical Instruments Corp.
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 93d
Cleared Oct 20, 1994
LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
K943732 · Graphic Controls Corp.
HGP · Electrode, Circular (spiral), Scalp And Applicator · 79d
Cleared Oct 20, 1994
IMAGYN LAPAROSCOPIC INSTRUMENTS
K944129 · Imagyn Medical, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 57d
Cleared Oct 17, 1994
HYSTEROMED 100
K930912 · Northgate Technologies, Inc.
HIG · Insufflator, Hysteroscopic · 602d
Cleared Sep 28, 1994
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · Carl Zeiss, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 553d
Cleared Sep 27, 1994
TUBAL LUMEN SUPPORT
K932114 · Cook Ob/Gyn
HFJ · Prosthesis, Fallopian Tube · 512d
Cleared Sep 14, 1994
SURGIMAT
K926259 · W.O.M. World of Medicine GmbH
HET · Laparoscope, Gynecologic (and Accessories) · 635d
Cleared Aug 30, 1994
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
K925560 · Zinnanti Surgical Instruments, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 665d
Cleared Aug 19, 1994
NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 6600
K935862 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 259d
Cleared Aug 19, 1994
SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
K936071 · Smith & Nephew Dyonics, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 242d
Cleared Aug 18, 1994
C-SECTION TRAY
K940518 · Cush Medical Products
MLS · Labor And Delivery Kit · 195d
Cleared Aug 15, 1994
MODEL 118 FETAL/MATERNAL MONITOR
K934959 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 304d
Cleared Aug 15, 1994
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
K942887 · Hewlett-Packard Co.
HGM · System, Monitoring, Perinatal · 56d
Cleared Aug 02, 1994
KLEENSPEC
K941272 · Welch Allyn, Inc.
HIB · Speculum, Vaginal, Nonmetal · 139d
Cleared Jul 28, 1994
SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS
K930773 · Symbiosis Corp.
HFB · Forceps, Biopsy, Gynecological · 527d
Cleared Jul 27, 1994
PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194
K941044 · Playtex, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 142d
Cleared Jul 25, 1994
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR
K930867 · United States Surgical, A Division of Tyco Healthc
LKF · Cannula, Manipulator/injector, Uterine · 521d
Cleared Jul 20, 1994
VIDEO ENDOSCOPE-RIGID MODIFICATION
K921294 · Medical Dynamics, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 855d
Cleared Jul 20, 1994
WALLACH LEEP PROCEDURE KIT
K935634 · Wallach Surgical Devices, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 239d
Cleared Jul 08, 1994
PLAYTEX TAMPONS MODEL 13794
K942418 · Playtex, Inc.
HEB · Tampon, Menstrual, Unscented · 49d
Cleared Jun 30, 1994
IRRIGATION PUMP AND TUBING SET
K924611 · Marlo Surgical Technology
HET · Laparoscope, Gynecologic (and Accessories) · 657d
Cleared Jun 30, 1994
THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV
K930954 · Cabot Medical Corp.
HIB · Speculum, Vaginal, Nonmetal · 492d
Cleared Jun 27, 1994
ELECTROSURGICAL ELECTRODE
K925478 · Megadyne Medical Products, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 606d
Cleared Jun 27, 1994
O.B. TAMPON
K941863 · Personal Products Co.
HEB · Tampon, Menstrual, Unscented · 73d

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All categories 3164 NUC Lubricant, Personal 230 HET Laparoscope, Gynecologic (and Accessories) 225 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 206 HIS Condom 197 HEB Tampon, Menstrual, Unscented 157 HGM System, Monitoring, Perinatal 155 HIH Hysteroscope (and Accessories) 145 HIF Insufflator, Laparoscopic 131 HIL Tampon, Menstrual, Scented, Scented-deodorized 75 HHD Pad, Menstrual, Unscented 64 LKF Cannula, Manipulator/injector, Uterine 61 HHL Pad, Menstrual, Scented, Scented-deodorized 45 HIG Insufflator, Hysteroscopic 43 MQK Labware, Assisted Reproduction 43