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
1051–1075 of 1727
Cleared Oct 28, 1996
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
K960299 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 280d
Cleared Oct 22, 1996
KSEA CULDOCENTESIS SET
K962881 · Karl Storz Endoscopy
HEW · Culdoscope (and Accessories) · 90d
Cleared Oct 03, 1996
KARL STORZ MODEL 203020 20 EQUIMAT
K961091 · KARL STORZ Endoscopy-America, Inc.
HIG · Insufflator, Hysteroscopic · 198d
Cleared Sep 30, 1996
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
K962090 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 124d
Cleared Sep 24, 1996
INSUFFLATION NEEDLE
K963359 · Applied Medical Resources
HET · Laparoscope, Gynecologic (and Accessories) · 29d
Cleared Aug 29, 1996
CERVICAL MUCOUS ASPIRATION CATHETER
K960263 · Cook Urological, Inc.
HFC · Aspirator, Endocervical · 224d
Cleared Aug 29, 1996
A4907 LENS CLEANING SHEATH
K961860 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 107d
Cleared Aug 13, 1996
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc.
HEB · Tampon, Menstrual, Unscented · 49d
Cleared Aug 08, 1996
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K961752 · Ackrad Laboratories
LKF · Cannula, Manipulator/injector, Uterine · 94d
Cleared Jul 24, 1996
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
K960936 · Origin Medsystems, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 138d
Cleared Jul 17, 1996
KSEA SCALP BLOOD COLLECTION SET
K954982 · KARL STORZ Endoscopy-America, Inc.
HGK · Endoscope, Fetal Blood Sampling (and Accessories) · 260d
Cleared Jul 10, 1996
INTRAN 500
K961424 · Utah Medical Products, Inc.
HFN · Transducer, Pressure, Intrauterine · 89d
Cleared Jul 03, 1996
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
K961993 · Devon Industries, Inc.
MLS · Labor And Delivery Kit · 43d
Cleared Jun 18, 1996
CONMED VCARE RETRACTOR/ELEVATOR
K955446 · Conmedcorp
LKF · Cannula, Manipulator/injector, Uterine · 202d
Cleared May 16, 1996
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K950335 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 475d
Cleared May 07, 1996
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
K955635 · Welch Allyn, Inc.
HEX · Colposcope (and Colpomicroscope) · 148d
Cleared Apr 29, 1996
PEDI VAGINAL ASPIRATOR
K954903 · Cook Urological, Inc.
HFC · Aspirator, Endocervical · 187d
Cleared Apr 29, 1996
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
K955093 · Utah Medical Products, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 174d
Cleared Apr 23, 1996
ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
K940176 · Ackrad Laboratories
MFD · Cannula, Intrauterine Insemination · 833d
Cleared Apr 17, 1996
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K960341 · Tambrands, Inc.
HEB · Tampon, Menstrual, Unscented · 84d
Cleared Apr 17, 1996
CAREFREE PANTYLINERS
K961119 · Personal Products Co.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 27d
Cleared Apr 15, 1996
CORING MORCELLATOR
K960262 · Cook Urological, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 88d
Cleared Apr 11, 1996
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K951343 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 384d
Cleared Mar 14, 1996
G.E. STERILE AMNIOCENTESIS TRAY
K960203 · GE Medical Systems
HIO · Sampler, Amniotic Fluid (amniocentesis Tray) · 58d
Cleared Mar 14, 1996
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc.
HHT · Spatula, Cervical, Cytological · 42d

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All categories 1727 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 NUC Lubricant, Personal 121 MQL Media, Reproductive 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 HIL Tampon, Menstrual, Scented, Scented-deodorized 24 MQF Catheter, Assisted Reproduction 24