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
1727 Obstetrics & Gynecology devices
1101–1125 of 1727
Cleared Aug 29, 1995
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K953034 · Ackrad Laboratories
LKF · Cannula, Manipulator/injector, Uterine · 71d
Cleared Aug 25, 1995
HAND EXTRACTOR HECTOR
K953109 · Karl Storz Endoscopy
HIH · Hysteroscope (and Accessories) · 53d
Cleared Aug 10, 1995
STRYKER OPERATING LAPAROSCOPE
K943100 · Stryker Endoscopy
HET · Laparoscope, Gynecologic (and Accessories) · 407d
Cleared Aug 04, 1995
V. MUELLER OBSTETRICAL (OB) FORCEPS
K951529 · Baxter Healthcare Corp
HDA · Forceps, Obstetrical · 123d
Cleared Aug 04, 1995
ELECTRONIC LAPAROFLATOR
K951694 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 114d
Cleared Aug 01, 1995
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
K951961 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 97d
Cleared Jul 28, 1995
NOVY CORNUAL CANNULATION SET
K931476 · Cook Ob/Gyn
MOV · Catheters, Salpingography · 856d
Cleared Jul 28, 1995
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
K952344 · Tambrands, Inc.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 70d
Cleared Jul 24, 1995
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
K950498 · Graphic Controls Corp.
KXO · Monitor, Pressure, Intrauterine · 168d
Cleared Jul 20, 1995
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE
K951394 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 114d
Cleared Jul 12, 1995
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K950962 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 132d
Cleared Jun 19, 1995
KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS
K950639 · KARL STORZ Endoscopy-America, Inc.
MOK · Vaginoscope And Accessories · 126d
Cleared Jun 15, 1995
B-D DIGITAL THERMOMETER
K945427 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LHD · Device, Fertility Diagnostic, Proceptive · 223d
Cleared Jun 14, 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951190 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared May 25, 1995
KSE STEINER ELECTROMECHANIC MORCELLATOR
K946147 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 160d
Cleared May 25, 1995
LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000
K950708 · Graphic Controls Corp.
KXO · Monitor, Pressure, Intrauterine · 101d
Cleared May 25, 1995
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
K950961 · KARL STORZ Endoscopy-America, Inc.
HIG · Insufflator, Hysteroscopic · 84d
Cleared May 11, 1995
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
K946359 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 132d
Cleared May 11, 1995
COOK INSEMINATION CUP
K950714 · Cook Urological, Inc.
HDR · Cap, Cervical · 85d
Cleared May 05, 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 165d
Cleared May 04, 1995
VAGINAL CONTINENCE DEVICE
K930618 · Johnson & Johnson Medical, Inc.
HHW · Pessary, Vaginal · 815d
Cleared May 04, 1995
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
K933654 · Johnson & Johnson Medical, Inc.
HHW · Pessary, Vaginal · 646d
Cleared Apr 25, 1995
AESCULAP LAPAROSCOPES
K942730 · Aesculap, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 320d
Cleared Apr 19, 1995
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
K941743 · Cabot Medical Corp.
HIG · Insufflator, Hysteroscopic · 377d
Cleared Apr 11, 1995
LUMIN
K943448 · Utah Medical Products, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 267d

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All categories 1727 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 MQL Media, Reproductive 121 NUC Lubricant, Personal 121 HIH Hysteroscope (and Accessories) 106 HEB Tampon, Menstrual, Unscented 100 HGM System, Monitoring, Perinatal 86 HIF Insufflator, Laparoscopic 80 HHD Pad, Menstrual, Unscented 54 LKF Cannula, Manipulator/injector, Uterine 43 HHL Pad, Menstrual, Scented, Scented-deodorized 38 HIS Condom 37 HIG Insufflator, Hysteroscopic 27 MQF Catheter, Assisted Reproduction 24 OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 24