PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR— 510(k) K993976
Substantially EquivalentThe Prometheus Group
FDA 510(k) clearance K993976 for PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR, Substantially Equivalent on 2000-02-22. Applicant: The Prometheus Group. Device class: 2.
Clearance details
- Applicant
- The Prometheus Group
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Duxbury, MA, US
Recent devices under product code KPI
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- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
More clearances from The Prometheus Group
view all- K160792 — Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
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- K023906 — PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
- K001515 — PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
- K974036 — PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.