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
4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
Cleared
Feb 12, 2002
DRG REACTION CHAMBER/SAFETY TIP
HEI
Monitor, Heart-valve Movement, Fetal, Ultrasonic
230d
Cleared
Feb 11, 2002
PORTEX RING PESSARY PVC-NON STERILE
HHW
Pessary, Vaginal
207d
Cleared
Feb 11, 2002
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
MQH
Microtools, Assisted Reproduction (pipettes)
173d
Cleared
Feb 11, 2002
TEKNO-MEDICAL OBSTETRICAL FORCEPS
HDA
Forceps, Obstetrical
90d
Cleared
Feb 08, 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
MQG
Accessory, Assisted Reproduction
51d
Cleared
Feb 01, 2002
TROJAN CRYSTAL CLEAR LIQUID
NUC
Lubricant, Personal
88d
Cleared
Jan 24, 2002
SAFE
HIS
Condom
72d
Cleared
Jan 18, 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
MQL
Media, Reproductive
87d
Cleared
Jan 17, 2002
SWIFT LOW PROFILE CUP (PRO CUP)
HDB
Extractor, Vacuum, Fetal
91d
Cleared
Jan 17, 2002
TOCO LITE, MODEL TD-01
HFM
Monitor, Uterine Contraction, External (for Use In Clinic)
90d
Cleared
Jan 17, 2002
GLOBAL HEALTHCARE VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
59d
Cleared
Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
HIH
Hysteroscope (and Accessories)
57d
Cleared
Jan 11, 2002
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
HGM
System, Monitoring, Perinatal
30d
Cleared
Jan 08, 2002
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
HIG
Insufflator, Hysteroscopic
207d
Cleared
Jan 08, 2002
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
61d
Cleared
Jan 07, 2002
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
HGX
Pump, Breast, Powered
172d
Cleared
Dec 27, 2001
BIOTEQUE VAGINAL PESSARIES
HHW
Pessary, Vaginal
86d
Cleared
Dec 21, 2001
GLO-SPEC
HIB
Speculum, Vaginal, Nonmetal
35d
Cleared
Dec 20, 2001
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
HGY
Pump, Breast, Non-powered
84d
Cleared
Dec 17, 2001
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
LKF
Cannula, Manipulator/injector, Uterine
14d
Cleared
Dec 14, 2001
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
MQG
Accessory, Assisted Reproduction
60d
Cleared
Dec 14, 2001
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
MQG
Accessory, Assisted Reproduction
36d
Cleared
Dec 13, 2001
WET LIGHT PERSONAL MOISTURIZER
HIS
Condom
90d
Cleared
Nov 30, 2001
IUI, MODEL 4220
MQF
Catheter, Assisted Reproduction
39d
Cleared
Nov 30, 2001
EMTRAC
MQF
Catheter, Assisted Reproduction
38d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices