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
1732 Obstetrics & Gynecology devices
1451–1475 of 1732
Cleared Aug 25, 1988
HYSTEROSCOPE AUTONOM 4992
K880314 · Richard Wolf Medical Instruments Corp.
HIH · Hysteroscope (and Accessories) · 212d
Cleared Aug 02, 1988
SIEMENS INTRAVAGINAL TRANSDUCER
K881405 · Siemens Medical Solutions USA, Inc.
HGL · Transducer, Ultrasonic, Obstetric · 120d
Cleared Aug 02, 1988
KOTEX LIGHTDAYS LONGS DEODORANT & REG. PANTILINERS
K882364 · Kimberly-Clark Corp.
HHD · Pad, Menstrual, Unscented · 55d
Cleared Jul 25, 1988
EURO-MED ENDO-CURETTE
K882606 · Buckman Co., Inc.
PCF · Sampler, Endocervical · 31d
Cleared Jul 15, 1988
ACKRAD H/S PROCEDURE TRAY
K881680 · Ackrad Laboratories
HIG · Insufflator, Hysteroscopic · 87d
Cleared Jun 22, 1988
ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60
K882185 · Richard Wolf Medical Instruments Corp.
HIF · Insufflator, Laparoscopic · 29d
Cleared Jun 10, 1988
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
K880419 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 130d
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 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 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 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

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All categories 1732 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 81 HHD Pad, Menstrual, Unscented 54 LKF Cannula, Manipulator/injector, Uterine 43 HHL Pad, Menstrual, Scented, Scented-deodorized 38 HIS Condom 37 HIG Insufflator, Hysteroscopic 28 HIL Tampon, Menstrual, Scented, Scented-deodorized 24 MQF Catheter, Assisted Reproduction 24