PATHWAY STM-10 PELVIC FLOOR STIMULATOR


Device Classification Name

stimulator, electrical, non-implantable, for incontinence

510(k) Number K030039
Device Name PATHWAY STM-10 PELVIC FLOOR STIMULATOR
Original Applicant
THE PROMETHEUS GROUP
2 mallards cove
duxbury, 
MA 
02332

Original Contact peter sullivan
Regulation Number 876.5320
Classification Product Code
KPI  
Date Received 01/06/2003
Decision Date 05/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No