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
- HIRPerineometer2Product Code
- K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)2Cleared 510(K)
- K231875Vaginal Tactile Ultrasound Imager2Cleared 510(K)
- K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)2Cleared 510(K)
- K231780Perifit Care+2Cleared 510(K)
- K221476Perifit2Cleared 510(K)
- K213913leva Pelvic Health System2Cleared 510(K)
- K212655Flyte2Cleared 510(K)
- K212495Leva Pelvic Health System2Cleared 510(K)
- K210764Flyte2Cleared 510(K)
- K193364Intimate Rose Kegel Exercise System2Cleared 510(K)
- K200409Pelvital System2Cleared 510(K)
- K192270LEva Pelvic Digital Health System2Cleared 510(K)
- K180637leva Pelvic Floor Trainer2Cleared 510(K)
- K171896Feminine Personal Trainer (FPT)2Cleared 510(K)
- K162689Vibrance Pelvic Trainer2Cleared 510(K)
- K160758PeriCoach OTC2Cleared 510(K)
- K142355Vaginal Tactile Imager2Cleared 510(K)
- K143580PeriCoach2Cleared 510(K)
- K141893VIBRANCE KEGEL DEVICE (VKD)2Cleared 510(K)
- K133990IEVA REHABILITATIVE POSITIONAL DEVICE2Cleared 510(K)
- K140780KEGEL SMART, KEGELSMART PEARL2Cleared 510(K)
- K122800INNER PEACE2Cleared 510(K)
- K121902NATRATONE2Cleared 510(K)
- K082436EXTT-1012Cleared 510(K)
- K023305KEGELMASTER 20002Cleared 510(K)
- K021115GYNEFLEX2Cleared 510(K)
- K011688PELVICFLEXER EXERCISE DEVICE2Cleared 510(K)
- K013612INCARE PELVIC FLOOR THERAPY SYSTEM2Cleared 510(K)
- K013653INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE2Cleared 510(K)
- K002043PELVEX HOMETRAINER2Cleared 510(K)
- K002617PERIFORM PERINEOMETRIC PROBE, MODEL 83002Cleared 510(K)
- K002830PELVIC MUSCLE THERAPY2Cleared 510(K)
- K002834SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR2Cleared 510(K)
- K994079REFLEX TREATMENT SYSTEM2Cleared 510(K)
- K993411FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR2Cleared 510(K)
- K981277PERIFORM2Cleared 510(K)
- K983052PERITRON PERINEOMETER MODEL 9300V OR 9300A2Cleared 510(K)
- K974036PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE2Cleared 510(K)
- K970145PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)2Cleared 510(K)
- K960508PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-252Cleared 510(K)
- K960311PERINEOMETER2Cleared 510(K)
- K945611PERITRON2Cleared 510(K)
- K952688INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE2Cleared 510(K)
- K925681MYOTRAC2D/CS2Cleared 510(K)
- K934552PERIPUMP2Cleared 510(K)
- K945937TE-800 PELVIC FLOOR EXERCISER2Cleared 510(K)
- K942563ELITE BIOFEEDBACK2Cleared 510(K)
- K935213INCONTROL2Cleared 510(K)
- K932149THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE2Cleared 510(K)
- K940091INNOVA VAGINAL EMG SENSING ELECTRODE2Cleared 510(K)
- K926218EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)2Cleared 510(K)
- K913912VERIMED PERINEOMETER2Cleared 510(K)
- K911190PERRYMETER(TM)2Cleared 510(K)
- K892888EXTACISER PERINEAL MUSCLE EXERCISER2Cleared 510(K)
- K891774CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI2Cleared 510(K)
- K862410MILEX KEGEL PERINEAL EXERCISER2Cleared 510(K)
- K861858VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 23632Cleared 510(K)
- K854193ELECTRO-MYOGRAPHIC PERINEOMETER2Cleared 510(K)
- K861683MONSANTO SANTOPRENE (PERITONE DEVICE)2Cleared 510(K)
- K860552PERITONE DISPOSAL SHEATH - RUBBER AND VINYL2Cleared 510(K)
- K821664PP-100, PERSONAL PERINEOMETER2Cleared 510(K)
- K800191PERITONE2Cleared 510(K)
- K800303ELECTRONIC PERINEOMETER2Cleared 510(K)
- K782083VAGATEX2Cleared 510(K)
- OCQLaparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence2Product Code
- PTEEndoscopic Morcellator Gastroenterology2Product Code
- 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
- 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
GYNEFLEX
- Page Type
- Cleared 510(K)
- 510(k) Number
- K021115
- 510(k) Type
- Traditional
- Applicant
- NAISSANCE HOLDINGS, LC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/20/2002
- Days to Decision
- 256 days
- Submission Type
- Summary