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

1476–1500 of 1732

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 19, 1988

SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS

K873457 · Procter & Gamble Mfg. Co.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 144d

Cleared Dec 14, 1987

SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL

K872254 · Surgical Laser Technologies, Inc.

HHR · Laser, Surgical, Gynecologic · 208d

Cleared Nov 23, 1987

CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/

K871928 · Medline Industries, Inc.

HIF · Insufflator, Laparoscopic · 189d

Cleared Nov 16, 1987

MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE

K871579 · Sharplan Lasers, Inc.

HHR · Laser, Surgical, Gynecologic · 207d

Cleared Nov 16, 1987

INSUFFLATOR TUBING

K872860 · Medline Industries, Inc.

HIG · Insufflator, Hysteroscopic · 118d

Cleared Oct 20, 1987

ENDOMETRIAL SAMPLER

K872908 · Zinnanti Surgical Instruments, Inc.

HHK · Curette, Suction, Endometrial (and Accessories) · 88d

Cleared Oct 06, 1987

CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA

K872253 · Surgical Laser Technologies, Inc.

HHR · Laser, Surgical, Gynecologic · 139d

Cleared Sep 29, 1987

UTERINE INJECTOR 2MM

K873515 · Zinnanti Surgical Instruments, Inc.

HES · Insufflator, Carbon-dioxide, Uterotubal (and Accessories) · 29d

Cleared Sep 28, 1987

SPERM-SELECT ADDITIONAL INDICATION

K872849 · Pharmacia, Inc.

HDR · Cap, Cervical · 70d

Cleared Aug 28, 1987

ANNULAR ARRAY SCANHEAD

K871856 · Advanced Technology Laboratories, Inc.

HGL · Transducer, Ultrasonic, Obstetric · 108d

Cleared Jul 16, 1987

MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.

K871220 · Cooper Lasersonics, Inc.

HHR · Laser, Surgical, Gynecologic · 118d

Cleared Jul 14, 1987

TAMPAX DEODORANT TAMPON, SUPER

K872261 · Tambrands, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 34d

Cleared Jul 10, 1987

MODEL 26021C BIPOLAR COAGULATOR

K871745 · KARL STORZ Endoscopy-America, Inc.

HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 66d

Cleared Jul 10, 1987

ELECTRO-GYNE ELECTROSURGICAL GENERATOR

K871960 · Cabot Medical Corp.

KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 51d

Cleared Jul 10, 1987

TAMPAX DEODORANT TAMPON, SUPER PLUS

K872255 · Tambrands, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 30d

Cleared Jul 10, 1987

TAMPAX DEODORANT TAMPON, ORIGINAL REGULAR

K872256 · Tambrands, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 30d

Cleared Jul 10, 1987

TAMPAX PETAL SOFT DEODORANT TAMPON, REGULAR

K872257 · Tambrands, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 30d

Cleared Jul 10, 1987

TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER PLUS

K872258 · Tambrands, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 30d

Cleared Jul 10, 1987

TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER

K872259 · Tambrands, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 30d

Cleared Jul 10, 1987

TAMPAX DEODORANT TAMPON, SLENDER REGULAR

K872260 · Tambrands, Inc.

HIL · Tampon, Menstrual, Scented, Scented-deodorized · 30d

Cleared Jun 30, 1987

ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS

K871715 · Tambrands, Inc.

HEB · Tampon, Menstrual, Unscented · 57d

Cleared Jun 26, 1987

ORTHO* SPECIMEN COLLECTION CYTOBRUSH

K871552 · Ortho Diagnostic Systems, Inc.

HHT · Spatula, Cervical, Cytological · 65d

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