Anesthesiology
Review Panel
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- ChemistryReview Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- MXQStent, Urethral, External Sphincter, Permanent3Product Code
- NAZStimulator, BladderFProduct Code
- NCVLithotripter, Shockwave (For Treating Gallbladder Stones)3Product Code
- QGGEsophageal Sheath With Distal Balloon Anchor2Product Code
- EZZProsthesis, Vas Deferens3Product Code
- FAAReplacer, Urethral3Product Code
- FABReplacer, Ureteral3Product Code
- FACValve, Ureterovesicle3Product Code
- FAGProsthesis, Urethral Sphincter3Product Code
- FAODevice, Cystometric, Air3Product Code
- FBYCooler, Esophageal And Gastric3Product Code
- FBZCooler, Prostatic3Product Code
- LEIImplant, Anti-Gastroesophageal Reflux3Product Code
- LILMonitor, Penile TumescenceUProduct Code
- LJECatheter, NephrostomyUProduct Code
- LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUProduct Code
- LKXDevice, Thermal, HemorrhoidsUProduct Code
- LNLStimulator, Electrical For Sperm CollectionUProduct Code
- LNMAgent, Bulking, Injectable For Gastro-Urology Use3Product Code
- LNQIntestinal StimulatorFProduct Code
- LNRSystem, Photopheresis, Extracorporeal3Product Code
- LOADevice, Testicular Hypothermia3Product Code
- LQQColumns, Immunoadsorption In Extracorporeal Systems3Product Code
- LQSSpermatocele, AlloplasticUProduct Code
- LRLCushion, HemorrhoidUProduct Code
- LSTDevice, Erectile DysfunctionUProduct Code
- LTIImplant, Intragastric For Morbid Obesity3Product Code
- LXWColumn, Adsorption, Low Density, Lipoprotein3Product Code
- MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma3Product Code
- MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy3Product Code
- MERStent, Urethral, Prostatic, Permanent Or Semi-Permanent3Product Code
- MESStent, Urethral, Bulbous, Permanent Or Semi-Permanent3Product Code
- MIKDevice, Ultrasonic, Thermal Ablation3Product Code
- MIPImplanted Fecal Incontinence Device3Product Code
- MMYLipoprotein, Low Density, Removal3Product Code
- MOAAnalyzer, Diagnostic, Fiber Optic (Colon)3Product Code
- MRESolution, Sodium Hyaluronate3Product Code
- NZCStent, Urethral, Prostatic, Semi-Permanent3Product Code
- OAYLight Source System, Diagnostic Endoscopic3Product Code
- OCKTransurethral Occlusion Insert, Urinary Incontinence-Control, Female3Product Code
- ODHImplantable Bladder-Evacuation Electrical Stimulation SystemFProduct Code
- OKNHyperthermia System, Bladder Cancer Treatment, With Chemotherapy3Product Code
- OVLHemodialyzer, High Cut-OffFProduct Code
- OYFAspiration Therapy System3Product Code
- PATBladder SystemFProduct Code
- PAZElectrical Stimulation Bladder SystemFProduct Code
- PBNApheresis For Focal Glomerulosclerosis In Adult And Pediatric PatientsFProduct Code
- PDIBeta 2-Microglobulin Apheresis ColumnFProduct Code
- PFEGastrointestinal Liner SystemNProduct Code
- PHNProtective Coating, Mucoadhesive Application, For The Rectal MucosaUProduct Code
- PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs3Product Code
- PIKMetabolic Neuromodulation SystemNProduct Code
- PIMNeuromodulator For Obesity3Product Code
- PMHMechanical Compression Device Fecal Incontinence (Non-Manually Operated)FProduct Code
- QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation3Product Code
- QLOImmunoadsorption Column For Emergency UseNProduct Code
- QMKExtracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During Public Health EmergenNProduct Code
- QNBPlasma Processing System For Converting Alpha To Pre-Beta High-Density LipoproteinFProduct Code
- QQKNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation3Product Code
- QRHCatheter, Balloon, Urethral, Drug-Coated3Product Code
- QPTStimulator, Tibial, Electrical, Implantable, For Urinary Incontinence3Product Code
- QSWEndoscopic Traction Device2Product Code
- QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss2Product Code
- QTHEndoscopic Light-Projecting Measuring Device2Product Code
- QTNOrally Ingested Transient Device For Constipation2Product Code
- QUDBlood Detection Capsule2Product Code
- QUNTether Accessory For Use In The Gastrointestinal Tract2Product Code
- QWWNon-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.2Product Code
- QXHGallbladder Drainage Stent And Delivery System2Product Code
- QXMImplanted Tibial Electrical Urinary Continence Device2Product Code
- QEJFlushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries2Product Code
- QXBDrug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia3Product Code
- QZFGastrointestinal Capsule Endoscopy Analysis Software Device2Product Code
- SAKSoftware Device To Aid In The Prediction Or Diagnosis Of Sepsis2Product Code
- SCBDeflation Needle For Removal Of Intragastric Balloon2Product Code
- QNAUltrasonic Urinary Stone Propulsion Device2Product Code
- SDQAlfapump System3Product Code
- SDKTransdermal Test For Assessment Of Glomerular Filtration Rate3Product Code
- SFWCranial Electrotherapy Stimulator For Weight Management1Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
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Implanted Tibial Electrical Urinary Continence Device
- Page Type
- Product Code
- Definition
- An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.
- Physical State
- The device includes an implanted battery less neurostimulator, an external power source (may be wearable) which gets connected to the implanted component to supply power and a software interface for the clinicians to set-up and monitor the stimulation parameters.
- Technical Method
- The implanted neurostimulator, powered by an external (non-implanted) power source, sends electrical pulses to the tibial nerve in proximity to the ankle to treat urge urinary incontinence, urinary urgency and/or urinary frequency related symptoms.
- Target Area
- Tibial nerve in proximity to the ankle.
- Regulation Medical Specialty
- Gastroenterology and Urology
- Review Panel
- Gastroenterology and Urology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 876.5305
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QXM is linked to regulation 21CFR876.5305, which does not seem to exist yet. It may be pending at the moment.