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
1729 Obstetrics & Gynecology devices
1301–1325 of 1729
Cleared Feb 07, 1991
BARD UTERINE MANIPULATOR
K904079 · C.R. Bard, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 155d
Cleared Feb 05, 1991
SONICAID MODEL MERIDIAN 800
K902690 · Oxford Medilog, Inc.
HGM · System, Monitoring, Perinatal · 231d
Cleared Jan 29, 1991
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE
K904745 · Graphic Controls Corp.
HGP · Electrode, Circular (spiral), Scalp And Applicator · 103d
Cleared Jan 29, 1991
FETAL MONITORING SPIRAL ELECTRODE
K905130 · Graphic Controls Corp.
HGP · Electrode, Circular (spiral), Scalp And Applicator · 75d
Cleared Jan 24, 1991
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
K904907 · Ethicon, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 85d
Cleared Dec 10, 1990
INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS
K904173 · Baxter Healthcare Corp
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared Dec 06, 1990
V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES
K904143 · Baxter Healthcare Corp
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared Dec 05, 1990
ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR
K904104 · Ethicon, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared Dec 05, 1990
GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS
K904142 · Baxter Healthcare Corp
HET · Laparoscope, Gynecologic (and Accessories) · 89d
Cleared Nov 16, 1990
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K902722 · Davol, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 149d
Cleared Oct 23, 1990
AUTO SUTURE LAPAROSCOPY ACCESSORY KIT
K903780 · United States Surgical, A Division of Tyco Healthc
HET · Laparoscope, Gynecologic (and Accessories) · 64d
Cleared Oct 22, 1990
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K903348 · Advanced Technology Laboratories, Inc.
HGL · Transducer, Ultrasonic, Obstetric · 88d
Cleared Oct 17, 1990
AUTO SUTURE(R) ENDOSCOPIC SCISSORS
K903206 · United States Surgical, A Division of Tyco Healthc
HET · Laparoscope, Gynecologic (and Accessories) · 89d
Cleared Oct 12, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K903124 · Cook, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 88d
Cleared Oct 12, 1990
HYSTEROSCOPY SHEATH SET
K903146 · Cook, Inc.
HIH · Hysteroscope (and Accessories) · 86d
Cleared Oct 12, 1990
LAPAROSCOPIC CATHERTER
K903187 · Cook Ob/Gyn
HET · Laparoscope, Gynecologic (and Accessories) · 85d
Cleared Oct 11, 1990
AUTO SUTURE(R) ENDOSCOPIC CLAMP
K903205 · United States Surgical, A Division of Tyco Healthc
HDA · Forceps, Obstetrical · 83d
Cleared Oct 10, 1990
DAVOL SCOPE IRRIGATION SYSTEM
K901288 · C.R. Bard, Inc.
HIG · Insufflator, Hysteroscopic · 204d
Cleared Oct 05, 1990
MINISPACE(TM) IUI CATHETER
K902171 · Pharmacia, Inc.
HDR · Cap, Cervical · 144d
Cleared Oct 05, 1990
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
K904358 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 11d
Cleared Sep 28, 1990
O. B. PACK IV
K902032 · Customed, Inc.
HFC · Aspirator, Endocervical · 147d
Cleared Sep 27, 1990
GARDOSI BIRTHING CUSHION
K903973 · Graphic Controls Corp.
KNC · Table, Obstetric (and Accessories) · 30d
Cleared Sep 26, 1990
TWIN BALLOON INJECTOR
K902975 · Zinnanti Surgical Instruments, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 82d
Cleared Sep 26, 1990
DEFLECTING WIRE GRASPER
K903707 · Cook, Inc.
HCZ · Forceps, Surgical, Gynecological · 42d
Cleared Sep 25, 1990
AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
K903207 · United States Surgical, A Division of Tyco Healthc
HET · Laparoscope, Gynecologic (and Accessories) · 67d

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All categories 1729 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 NUC Lubricant, Personal 121 MQL Media, Reproductive 121 HIH Hysteroscope (and Accessories) 107 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