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)
Show All 64 Submissions
- 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
Flyte
- Page Type
- Cleared 510(K)
- 510(k) Number
- K210764
- 510(k) Type
- Special
- Applicant
- Pelvital USA, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/13/2021
- Days to Decision
- 29 days
- Submission Type
- Statement