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
2751–2775 of 3170
Cleared Dec 20, 1988
MAXITHINS SUPER PADS, DEODORANT
K884446 · Tambrands, Inc.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 60d
Cleared Dec 20, 1988
ROCKET INTRAUTERINE DEPTH SOUND
K884684 · A & A Medical, Inc.
HHM · Sound, Uterine · 42d
Cleared Dec 08, 1988
TROJAN EXTRA STRENGTH LUBRICATED
K883413 · Carter Products
HIS · Condom · 115d
Cleared Dec 08, 1988
BAXTER DISPOSABLE CIRCUMCISION TRAY
K884290 · Baxter Healthcare Corp
HFX · Clamp, Circumcision · 57d
Cleared Dec 08, 1988
COOK HYSTEROCATH(TM)
K884291 · Cook, Inc.
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 57d
Cleared Dec 05, 1988
MAXITHINS REGULAR PADS, DEODORANT
K884444 · Tambrands, Inc.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 45d
Cleared Dec 05, 1988
MAXITHINS PANTY SHIELDS, DEODORANT
K884445 · Tambrands, Inc.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 45d
Cleared Dec 02, 1988
ALWAYS UNSCENTED MENSTRUAL PADS
K884428 · Procter & Gamble Co.
HHD · Pad, Menstrual, Unscented · 43d
Cleared Dec 02, 1988
ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD
K884429 · Procter & Gamble Co.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 43d
Cleared Oct 31, 1988
ROCKET INTRAUTERINE SOUND
K883806 · A & A Medical, Inc.
HHM · Sound, Uterine · 54d
Cleared Oct 20, 1988
KISS OF MINT(TM) NON-LUBRICATED CONDOM
K882389 · Ansell, Inc.
HIS · Condom · 132d
Cleared Oct 07, 1988
ROCKET CERVICAL SPATULA
K884042 · A & A Medical, Inc.
HHT · Spatula, Cervical, Cytological · 11d
Cleared Oct 05, 1988
MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM
K882966 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 82d
Cleared Oct 03, 1988
FEMALE CONTINENCE DEVICE
K883721 · Cook Ob/Gyn
HHW · Pessary, Vaginal · 33d
Cleared Sep 29, 1988
HYSTERO KIT
K882054 · Zinnanti Surgical Instruments, Inc.
HDP · Elevator, Uterine · 136d
Cleared Sep 15, 1988
EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM
K882605 · Buckman Co., Inc.
HIB · Speculum, Vaginal, Nonmetal · 83d
Cleared Aug 25, 1988
HYSTEROSCOPE AUTONOM 4992
K880314 · Richard Wolf Medical Instruments Corp.
HIH · Hysteroscope (and Accessories) · 212d
Cleared Aug 05, 1988
GL-35 COLPOSCOPIC LASER SYSTEM
K875314 · Laser Engineering, Inc.
HHR · Laser, Surgical, Gynecologic · 220d
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 19, 1988
C-E BRUSH
K881921 · Surgipath Medical Industries, Inc.
HHT · Spatula, Cervical, Cytological · 71d
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

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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