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
3163 Obstetrics & Gynecology devices
2251–2275 of 3163
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 26, 1995
NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS
K952070 · American Hydro-Surgical Instruments, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 85d
Cleared Jul 24, 1995
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
K950498 · Graphic Controls Corp.
KXO · Monitor, Pressure, Intrauterine · 168d
Cleared Jul 24, 1995
IMAGYN HYSTEROSCOPE
K952033 · Imagyn Medical, Inc.
HIH · Hysteroscope (and Accessories) · 84d
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 Jul 06, 1995
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
K946380 · American Hydro-Surgical Instruments, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 205d
Cleared Jun 22, 1995
TROJAN POLYURETHANE CONDOM
K942697 · Carter Products
MOL · Condom, Synthetic · 379d
Cleared Jun 22, 1995
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
K943933 · Aladan Corp.
HIS · Condom · 314d
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 16, 1995
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
K950499 · American Hydro-Surgical Instruments, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 130d
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 15, 1995
IMAGYN INTRAUTERINE INSEMINATION DEVICE
K945131 · Imagyn Medical, Inc.
HDR · Cap, Cervical · 208d
Cleared May 15, 1995
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
K950420 · Analogic Corp.
HGM · System, Monitoring, Perinatal · 104d
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 05, 1995
CANNUAL AND TROCAR, SUPERPUBIC
K950457 · Core Dynamics, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 91d
Cleared May 04, 1995
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
K921791 · Wallach Surgical Devices, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 1115d
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

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All categories 3163 NUC Lubricant, Personal 229 HET Laparoscope, Gynecologic (and Accessories) 225 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 206 HIS Condom 197 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 HIG Insufflator, Hysteroscopic 43 MQK Labware, Assisted Reproduction 43