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

3175 Obstetrics & Gynecology devices

2901–2925 of 3175

Cleared Jul 07, 1986

MODIFIED FETAL MONITOR MODEL FM-2

K861556 · Advantage Medical Systems, Inc.

HGM · System, Monitoring, Perinatal · 73d

Cleared Jul 07, 1986

K862358 · Hdc Corp.

KNE · Set, Anesthesia, Obstetric · 14d

Cleared Jun 19, 1986

ACUSON S228, S519 & L558 TRANSDUCERS

K861577 · Acuson Computed Sonography

HGL · Transducer, Ultrasonic, Obstetric · 52d

Cleared Jun 17, 1986

ACUSON S328, L382, L538 & L312 TRANSDUCERS

K861578 · Acuson Computed Sonography

HGL · Transducer, Ultrasonic, Obstetric · 50d

Cleared Jun 09, 1986

KOTEX PROFILE SHAPED MAXI PAD

K861902 · Kimberly-Clark Corp.

HHD · Pad, Menstrual, Unscented · 24d

Cleared Jun 02, 1986

5 MHZ INTRACAVITARY PROBE, MODEL H4222V

K860233 · General Electric Co.

HEM · Imager, Ultrasonic Obstetric-gynecologic · 131d

Cleared May 30, 1986

MODEL DT-102 DATA TELEPHONE TRANSMITTER

K861455 · Advantage Medical Systems, Inc.

HGM · System, Monitoring, Perinatal · 42d

Cleared May 23, 1986

TRANSVAGINAL TRANSDUCER, 5MHZ

K860234 · Philips Medical Systems, Inc.

HGL · Transducer, Ultrasonic, Obstetric · 121d

Cleared Apr 14, 1986

MX4040 INTRAUTERINE PRESSURE MONITORING KIT

K860101 · Medex, Inc.

KXO · Monitor, Pressure, Intrauterine · 94d

Cleared Apr 08, 1986

TECNOL SECURE-ALL FETAL MONITOR STRAP

K861189 · Tecnol New Jersey Wound Care, Inc.

HGM · System, Monitoring, Perinatal · 8d

Cleared Mar 17, 1986

HURWITZ AMNIOCENTESIS NEEDLE

K854725 · Bd Becton Dickinson Vacutainer Systems Preanalytic

HIO · Sampler, Amniotic Fluid (amniocentesis Tray) · 115d

Cleared Mar 17, 1986

3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031

K860313 · Johnson & Johnson Professionals, Inc.

HGL · Transducer, Ultrasonic, Obstetric · 48d

Cleared Mar 13, 1986

K860587 · Kimberly-Clark Corp.

HHD · Pad, Menstrual, Unscented · 22d

Cleared Mar 12, 1986

EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET

K853856 · Aequitron Medical, Inc.

HFM · Monitor, Uterine Contraction, External (for Use In Clinic) · 177d

Cleared Feb 21, 1986

ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY

K853876 · Endo Lase, Inc.

HHR · Laser, Surgical, Gynecologic · 157d

Cleared Feb 21, 1986

ENDO-LASE CD40 CO2 FOR GYNECOLOGY

K853903 · Endo Lase, Inc.

HHR · Laser, Surgical, Gynecologic · 154d

Cleared Feb 21, 1986

MEDILAS 2 ND:YAG LASER SURGERY SYSTEM

K855093 · Endo Lase, Inc.

HHR · Laser, Surgical, Gynecologic · 63d

Cleared Feb 04, 1986

CO2 LASER LAPAROSCOPE SYSTEM

K854361 · Richard Wolf Medical Instruments Corp.

HHR · Laser, Surgical, Gynecologic · 98d

Cleared Jan 24, 1986

MEDSURG AMNIOCENTESIS TRAY

K854290 · Medsurg Industries, Inc.

Cleared Dec 18, 1985

5.0 MHZ INTRACAVITARY SECTOR PROBE

K853711 · General Electric Co.

HEM · Imager, Ultrasonic Obstetric-gynecologic · 104d

Cleared Nov 19, 1985

WALLACH ZOOM COLPOSCOPE

K853389 · Wallach Surgical Devices, Inc.

HEX · Colposcope (and Colpomicroscope) · 98d

Cleared Nov 12, 1985

MODEL J25-25 WATT CO2 LASER

K851425 · Britt Corp., Inc.

HHR · Laser, Surgical, Gynecologic · 216d

Cleared Nov 07, 1985

BELIEVE HEAVY FLOW PROTECTION LABIAL PADS

K853630 · Kimberly-Clark Corp.

HHD · Pad, Menstrual, Unscented · 69d

Cleared Oct 29, 1985

WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL

K853640 · Downs Surgical , Ltd.

HDF · Speculum, Vaginal, Metal · 70d

Cleared Oct 23, 1985

OCS-2 COLPOSCOPE

K852980 · Olympus Corp.

HEX · Colposcope (and Colpomicroscope) · 100d

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