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
3170 Obstetrics & Gynecology devices
2776–2800 of 3170
Cleared Jun 01, 1988
PUDENDAL/LOCAL ANESTESIA BLOCK TRAY
K880988 · Bd Becton Dickinson Vacutainer Systems Preanalytic
KNE · Set, Anesthesia, Obstetric · 85d
Cleared Jun 01, 1988
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
K881185 · Philips Medical Systems (Cleveland), Inc.
HEM · Imager, Ultrasonic Obstetric-gynecologic · 72d
Cleared May 25, 1988
LASER OPTICAL CATHETER SYSTEM
K880991 · Medline Industries, Inc.
HHR · Laser, Surgical, Gynecologic · 78d
Cleared May 24, 1988
NEZHAT IRRIGATION PUMP SYSTEM
K880763 · Cabot Medical Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 89d
Cleared May 23, 1988
LAMINARIA
K881312 · Busse Hospital Disposables, Inc.
HDY · Dilator, Cervical, Hygroscopic-laminaria · 56d
Cleared Apr 27, 1988
UMBILICAL CORD CLAMP
K880753 · I M, Inc.
HFW · Clamp, Umbilical · 62d
Cleared Apr 25, 1988
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K880734 · Personal Products Co.
HHI · System, Abortion, Vacuum · 61d
Cleared Apr 25, 1988
UNSCENTED MENSTRUAL PADS
K880735 · Personal Products Co.
HHD · Pad, Menstrual, Unscented · 61d
Cleared Apr 21, 1988
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
K881010 · Sharplan Lasers, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 42d
Cleared Apr 06, 1988
MEDELA BREAST-PUMP LACTINA
K875300 · Medela, Inc.
HGX · Pump, Breast, Powered · 99d
Cleared Mar 24, 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875334 · Kontron Instruments, Inc.
HGL · Transducer, Ultrasonic, Obstetric · 85d
Cleared Mar 24, 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875371 · Kontron Instruments, Inc.
HGL · Transducer, Ultrasonic, Obstetric · 84d
Cleared Mar 24, 1988
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
K880173 · Cooper Lasersonics, Inc.
HHR · Laser, Surgical, Gynecologic · 69d
Cleared Mar 22, 1988
PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER
K881057 · Playtex, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 11d
Cleared Mar 14, 1988
KTP/532 LASER FOR OB-GYN USE
K874837 · Laserscope
HHR · Laser, Surgical, Gynecologic · 111d
Cleared Mar 08, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS
K880024 · Tambrands, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 63d
Cleared Mar 02, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON
K880022 · Tambrands, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 57d
Cleared Mar 02, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON
K880023 · Tambrands, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 57d
Cleared Feb 26, 1988
DECHERNEY HYSTEROSCOPY PUMP SYSTEM
K873527 · Cabot Medical Corp.
HIG · Insufflator, Hysteroscopic · 178d
Cleared Feb 08, 1988
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K875084 · Cabot Medical Corp.
HHK · Curette, Suction, Endometrial (and Accessories) · 61d
Cleared Feb 02, 1988
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
K870841 · Directed Energy, Inc.
HHR · Laser, Surgical, Gynecologic · 341d
Cleared Feb 02, 1988
MODEL 20-C, RL-20A/U, OB-10A/U
K872709 · Directed Energy, Inc.
HHR · Laser, Surgical, Gynecologic · 210d
Cleared Jan 28, 1988
CABOT FIBER LASER PROBE
K873115 · Cabot Medical Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 171d
Cleared Jan 27, 1988
ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
K875162 · Ortho Diagnostic Systems, Inc.
HHT · Spatula, Cervical, Cytological · 42d
Cleared Jan 20, 1988
LASER LAPAROSCOPY SET
K873598 · Cuda Products Co.
HET · Laparoscope, Gynecologic (and Accessories) · 138d

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All categories 3170 NUC Lubricant, Personal 230 HET Laparoscope, Gynecologic (and Accessories) 225 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 207 HIS Condom 199 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 MQK Labware, Assisted Reproduction 43 HIG Insufflator, Hysteroscopic 43