FDA Device Explorer

Obstetrics/Gynecology (OB) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Obstetrics/Gynecology (OB) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 866, Part 876, Part 882, Part 884

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
ONXOvarian Adnexal Mass Assessment Score Test System866.605026
QAGEndoscopic Electrosurgical Clip Cutting System876.431021
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder882.580324
LHZViscometer, Mucus, Cervical884.104011
HFCAspirator, Endocervical884.1050211
PCFSampler, Endocervical884.105025
HFFAspirator, Endometrial884.106025
HFEBrush, Endometrial884.110029
HHKCurette, Suction, Endometrial (And Accessories)884.1175242
OKZEndometrial Sampling Kit884.117520
HFDWasher, Endometrial884.118523
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)884.1300213
HIRPerineometer884.1425264
HIOSampler, Amniotic Fluid (Amniocentesis Tray)884.1550120
HGWSampler, Blood, Fetal884.156024
PVSFetal Blood Sampling Kit (Excludes Hiv Testing)884.156020
HFAAmnioscope, Transabdominal (Fetoscope) (And Accessories)884.1600f0
HEXColposcope (And Colpomicroscope)884.1630256
MOKVaginoscope And Accessories884.163022
OHEForensic Evidence Sexual Assault Kit884.163020
PTZColposcope (And Colpomicroscope), Exempt884.163020
HEWCuldoscope (And Accessories)884.1640218
OHFCuldocentesis Kit884.164020
HEZEndoscope, Transcervical (Amnioscope)(And Accessories)884.166020
HGKEndoscope, Fetal Blood Sampling (And Accessories)884.166021
HIHHysteroscope (And Accessories)884.16902169
MKOFalloposcope884.169024
NWWHysteroscope Accessories884.169010
PTEEndoscopic Morcellator Gastroenterology884.169022
QHZSeal, Cervical, Mechanical, Unpowered884.169010
HIGInsufflator, Hysteroscopic884.1700256
NVTTubing And Tubing/Filter Fits884.170010
PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar884.171023
HETLaparoscope, Gynecologic (And Accessories)884.17202338
NMHLaparoscope And Accessories, Gynecologic, Reprocessed884.172020
NWVLaparoscopic Accessories, Gynecologic884.172010
OCQLaparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence884.172020
OHDGynecological Laparoscopic Kit884.172020
OHMCesarean Section Tray884.172020
OKXTrocar Kit884.172020
HIFInsufflator, Laparoscopic884.17302177
NKCTubing/Tubing With Filter, Insufflation, Laparoscopic884.173010
NMILaparoscopic Insufflator And Accessories, Reprocessed884.173010
OSVInsufflator, Endoscopic Vessel Harvesting884.173020
HEOAnalyzer, Data, Obstetric884.205031
HEMImager, Ultrasonic Obstetric-Gynecologic884.2225230
HENCaliper, Fetal Head, Ultrasonic884.222520
HHJLocator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic884.222521
HHXHolograph, Fetal, Acoustical884.222520
KXNMonitor, Cardiac, Fetal884.260022
HGOMonitor, Electroencephalographic, Fetal (And Accessories)884.262030
HFPMonitor, Phonocardiographic, Fetal884.264020
HEIMonitor, Heart-Valve Movement, Fetal, Ultrasonic884.266023
HEJMonitor, Hemic Sound, Ultrasonic884.266020
HEKMonitor, Heart Sound, Fetal, Ultrasonic884.266025
HELMonitor, Heart Rate, Fetal, Ultrasonic884.266027
HEPMonitor, Blood-Flow, Ultrasonic884.266024
HEQMonitor, Pressure, Arterial, Fetal, Ultrasonic884.266020
KNGMonitor, Ultrasonic, Fetal884.2660260
LXEDoppler, Fetal, Ultrasound884.266020
MAAMonitor, Fetal Doppler Ultrasound884.266029
HGPElectrode, Circular (Spiral), Scalp And Applicator884.2675217
HIQElectrode, Clip, Fetal Scalp (And Applicator)884.268530
HFNTransducer, Pressure, Intrauterine884.270029
HFORecorder, Pressure, Intrauterine884.270024
HGSCatheter, Intrauterine And Introducer884.270022
KXOMonitor, Pressure, Intrauterine884.2700226
HFMMonitor, Uterine Contraction, External (For Use In Clinic)884.2720224
OSPUterine Electromyographic Monitor884.2720210
LQKHome Uterine Activity Monitor884.273027
MOHMonitor, Heart Rate, Fetal, Non-Stress Test (Home Use)884.273020
HGMSystem, Monitoring, Perinatal884.27402214
HGNStethoscope, Fetal884.290012
HGLTransducer, Ultrasonic, Obstetric884.2960236
IYMSystem, Telethermographic, Infrared884.298038
LHPSystem, Telethermographic (Sole Diagnostic Screen)884.298030
LHQSystem, Telethermographic (Adjunctive Use)884.2980140
KXZSystem, Thermographic, Liquid Crystal, Powered (Adjunctive Use)884.298237
KYASystem, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)884.298215
LHMSystem, Thermographic, Liquid Crystal884.298211
LHRSystem, Thermographic, Liquid Crystal (Sole Diagnostic Screen)884.298230
NHMSheet, Recording, Breast Examination884.299022
NKASystem, Documentation, Breast Lesion884.299024
HFLDrain, Cervical884.320021
HHWPessary, Vaginal884.3575241
HFJProsthesis, Fallopian Tube884.365021
HDXDilator, Vaginal884.390029
HFKMold, Vaginal884.390021
KXPStent, Vaginal884.390024
PMUContainment System, Laparoscopic Power Morcellation, With Instrument Port884.405024
HIMElectrocautery, Endoscopic And Accessories884.410020
HGIElectrocautery, Gynecologic (And Accessories)884.4120253
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)884.4150216
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)884.4160211
HFHCoagulator, Hysteroscopic (And Accessories)884.416020
HFICoagulator, Culdoscopic (And Accessories)884.416028
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)884.4160244
HDNDilator, Cervical, Expandable884.425030
HDYDilator, Cervical, Hygroscopic-Laminaria884.4260211
PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To Labor884.426022
PKNDilator, Cervical, Synthetic, Osmotic884.426021
PONCatheter, Balloon, Dilation Of Cervical Canal884.426024
HHGDilator, Cervical, Vibratory884.427030
HDBExtractor, Vacuum, Fetal884.4340230
OHCObstetrical Vacuum Delivery Kit884.434020
PWBFetal Head Elevator884.435022
HDAForceps, Obstetrical884.4400210
HDIHook, Destructive, Obstetrical884.450020
HFZCraniotribe884.450020
HGACranioclast884.450020
HHNCleidoclast884.450020
KNBInstrument, Destructive, Fetal, Obstetric884.450021
HDEHook, Fibroid, Gynecological884.452010
HDFSpeculum, Vaginal, Metal884.4520111
HDGSpeculum, Vaginal, Metal, Fiberoptic884.452012
HDJScissors, Umbilical884.452011
HDKScissors, Episiotomy884.452010
HDLRetractor, Vaginal884.452012
HDMPacker, Uterine884.452010
HERPelvimeter, External884.452010
HGCClamp, Uterine884.452012
HGDApplicator, Vaginal884.452011
KOHInstrument, Manual, General Obstetric-Gynecologic884.4520115
OKUEmergency Obstetrical Kit884.452010
OKVObstetrical Kit884.452020
FHGBell, Circumcision884.453022
FHJShield, Circumcision884.453022
HCYCurette, Uterine884.4530111
HCZForceps, Surgical, Gynecological884.4530224
HDCTenaculum, Uterine884.4530220
HDHNeedle, Cerclage, Gynecological884.453010
HDPElevator, Uterine884.453024
HDQDilator, Cervical, Fixed Size884.453016
HDZKnife, Cervical Cone884.453020
HFBForceps, Biopsy, Gynecological884.4530122
HFWClamp, Umbilical884.4530236
HFXClamp, Circumcision884.4530227
HGEAmniotome884.453016
HHFRemover, Intrauterine Device, Contraceptive, Hook-Type884.453016
HHMSound, Uterine884.4530110
HHOScrew, Fibroid, Gynecological884.453022
HHTSpatula, Cervical, Cytological884.4530273
HIBSpeculum, Vaginal, Nonmetal884.4530272
HICSpeculum, Vaginal, Nonmetal, Fiberoptic884.453025
KNAInstrument, Manual, Specialized Obstetric-Gynecologic884.4530258
LBXPelvimeter, Internal884.453021
LKFCannula, Manipulator/Injector, Uterine884.4530287
MDGSystem, Intrafallopian Cannula884.453021
MLSLabor And Delivery Kit884.453026
MLTPelvic Exam Kit884.453021
MOVCatheters, Salpingography884.453025
MPUSource, Chemiluminescent Light884.453022
NBZClamp And Cutter, Umbilical884.453021
NMGForceps, Biopsy, Gynecological, Reprocessed884.453020
OHGCircumcision Tray884.453020
OHLPap Smear Kit884.453020
OJFHysterectomy Kit884.453020
OKYCytology Kit884.453020
OQYIntrauterine Tamponade Balloon884.4530210
PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use884.453028
PGKCannula, Injector, Uterine, Endometrial Biopsy884.453022
PUATenaculum, Uterine, Exempt884.453020
PVRD&C Tray884.453020
PVXVaginal Examination Tray884.453020
QQRCircumcision Device With Stapler884.453020
HHRLaser, Surgical, Gynecologic884.4550248
LLWLaser, Neodymium:Yag For Gynecologic Use884.455021
HDDTable, Obstetrical, Ac-Powered (And Accessories)884.490027
HHPTable, Obstetrical, Manual (And Accessories)884.490022
KNCTable, Obstetric (And Accessories)884.4900226
PWIInstrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse884.491022
PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence884.491025
PWKInstrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse884.491021
HHQSystem, Abortion, Metreurynter-Balloon884.505030
HGFSource, Abortion Unit, Vacuum884.507024
HGGController, Abortion Unit, Vacuum884.507021
HGHCannula, Suction, Uterine884.507026
HHISystem, Abortion, Vacuum884.5070224
HEESet, Anesthesia, Paracervical884.510029
HEGSet, Anesthesia, Pudendal884.510020
KNESet, Anesthesia, Obstetric884.510022
PVUObstetrical Anesthesia Kit884.510020
PVVParacervical Anesthesia Kit884.510020
PVWPudendal Anesthesia Kit884.510020
HGYPump, Breast, Non-Powered884.5150127
PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure884.515010
HGXPump, Breast, Powered884.51602233
OHHBreast Pump Kit884.516020
OOAHemorrhoid Prevention Pressure Wedge884.520021
PNUPressure Wedge, Perianal, For Reduction Of Cesarean Delivery884.521021
HEHChamber, Decompression, Abdominal884.522530
HDRCap, Cervical884.5250229
MFDCannula, Intrauterine Insemination884.5250229
OBBKit, Conception-Assist, Home Use884.525024
HISCondom884.53002400
MOLCondom, Synthetic884.5300223
MSCBarrier, Std, Oral Sex884.530026
NUCLubricant, Personal884.53002240
OKWSeminal Fluid Collection Kit884.530020
PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible884.5300210
QPDPersonal Lubricant Ring884.530021
QRZExternal Condom For Anal Intercourse Or Vaginal Intercourse884.530521
LTZCondom With Nonoxynol-9884.5310222
LZLMicro-Condom884.532030
OBYCondom, Female, Animal Tissue884.533030
MBUSingle-Use Internal Condom884.534023
HDWDiaphragm, Contraceptive (And Accessories)884.535024
MPTContraception Calculator884.535021
HDTDevice, Intrauterine, Contraceptive And Introducer884.536030
PYTDevice, Fertility Diagnostic, Contraceptive, Software Application884.537026
HDOValve, Tubal Occlusion884.538030
HFYBand, Tubal Occlusion884.538030
HGBClip, Tubal Occlusion884.538030
HHSTranscervical Contraceptive Tubal Occlusion Device884.538031
KNHLaparoscopic Contraceptive Tubal Occlusion Device884.538034
HGZHeater, Perineal, Direct Contact884.539021
HHAHeater, Perineal, Radiant, Non-Contact884.539020
KNDHeater, Perineal884.539020
HHECup, Menstrual884.5400216
HHLPad, Menstrual, Scented, Scented-Deodorized884.5425257
NRCPad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile884.542510
HHDPad, Menstrual, Unscented884.54351136
NUQPad, Menstrual, Reusable884.543511
NURPad, Menstrual, Intralabial884.543510
PVTMaternity Kit884.543510
HIL Tampon, Menstrual, Scented, Scented-Deodorized884.5460284
HEBTampon, Menstrual, Unscented884.54702189
HEDDouche Apparatus, Vaginal, Therapeutic884.5900112
HECInsufflator, Vaginal884.592010
HIIStimulator, Vaginal, Muscle, Powered, For Therapeutic Use884.594030
KXQVibrator For Therapeutic Use, Genital884.596024
NBVDevice, Engorgement, Clitoral884.597023
OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed884.5980331
PAIMesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed884.598032
MQENeedle, Assisted Reproduction884.6100232
NNBNeedle, Reproduction, Assisted, Reprocessed884.610020
MQFCatheter, Assisted Reproduction884.6110253
QYZAt Home Intravaginal Insemination System884.611023
MQGAccessory, Assisted Reproduction884.6120245
PUBAccessory, Assisted Reproduction, Exempt884.612021
QKHAssisted Reproduction Laminar Flow Workstation884.612020
QUJAutomated Cryopreservation Storage System884.612021
MQHMicrotools, Assisted Reproduction (Pipettes)884.6130226
PUCMicrotools, Assisted Reproduction (Pipettes), Exempt884.613020
MQIMicrotool Fabrication, Assisted Reproduction884.614020
MQJMicromanipulators And Microinjectors, Assisted Reproduction884.6150223
MQKLabware, Assisted Reproduction884.6160250
PUDLabware, Assisted Reproduction, Exempt884.616020
OYOCulture, Intravaginal, Assisted Reproduction884.616522
MTWSystem, Water, Reproduction, Assisted, And Purification884.617022
MQLMedia, Reproductive884.61802258
QKIMedia, Reproductive, Exempt884.618020
MTXMicroscope And Microscope Accessories, Reproduction, Assisted884.619010
PBHEmbryo Image Assessment System, Assisted Reproduction884.619524
MRXSystem, Assisted Reproduction Laser884.6200210
Innolitics

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