Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- 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
- KPNAlarm, Conditioned Response Enuresis2Product Code
- K130951SIM2Cleared 510(K)
- K971442HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-52Cleared 510(K)
- K971855POTTY PAL AND FOREVER-DRY2Cleared 510(K)
- K962770UROSURGE ACUTRAINER2Cleared 510(K)
- K962416DRYTIME FOR BLADDER CONTROL SILENT2Cleared 510(K)
- K955338DRYTIME FOR POTTY TRAINING2Cleared 510(K)
- K943558PRO'TECT2Cleared 510(K)
- K943559REMOTE A'LERT2Cleared 510(K)
- K942057FISHER-PRICE DRY NIGHT MONITOR2Cleared 510(K)
- K935915WET SENSE2Cleared 510(K)
- K934369DRI SLEEPER2Cleared 510(K)
- K930005DRITRAINER2Cleared 510(K)
- K921431POTTY PAGER2Cleared 510(K)
- K911279DRY TIME2Cleared 510(K)
- K903856WET-NO-MORE MONITOR2Cleared 510(K)
- K901907PROFESSIONAL MONITOR2Cleared 510(K)
- K901906WET-NO-MORE MONITOR2Cleared 510(K)
- K895852BUZZY BEAR ENURESIS ALARM2Cleared 510(K)
- K895251BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))2Cleared 510(K)
- K895346DR. DRY2Cleared 510(K)
- K885345HEALTHSHIELD2Cleared 510(K)
- K882555ANOTRON(R) INCONTINENCE CONTROL SYSTEM2Cleared 510(K)
- K872522BED ALERT2Cleared 510(K)
- K871787ENURESIS ALARM2Cleared 510(K)
- K864448THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM)2Cleared 510(K)
- K862683BIOSOICS SPHINCTER TRAINING SYSTEM2Cleared 510(K)
- K862757STARCHILD SLEEPDRY2Cleared 510(K)
- K854539UROSTAT2Cleared 510(K)
- K850538BED SENTRY, MODEL 50U2Cleared 510(K)
- K844866NYTONE ENURETIC ALARM BEDWETTING DEVICE2Cleared 510(K)
- K844636SENTRY SIGNAL ENURESIS ALARM SYSTEM2Cleared 510(K)
- K842547WET-STOP2Cleared 510(K)
- K834311NIGHT TRAINER2Cleared 510(K)
- K823276BED GUARD2Cleared 510(K)
- K821546MONITORING DEVICE ENURESIS ALARM & ACC.2Cleared 510(K)
- K782093DETECTOR PAD2Cleared 510(K)
- K780660NITE TRAIN'R2Cleared 510(K)
- OQTProstate Lesion, Documentation, System2Product Code
- QEFPressure Ulcer Management Tool1Product Code
- 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
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BIOSOICS SPHINCTER TRAINING SYSTEM
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K862683
- 510(k) Type
- Traditional
- Applicant
- BIOSONICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/12/1986
- Days to Decision
- 120 days