MAXIFLEX – SEMI FLEX SCOPE, 25 TO 65 CM


Device Classification Name

ureteroscope and accessories, flexible/rigid

510(k) Number K111480
Device Name MAXIFLEX – SEMI FLEX SCOPE, 25 TO 65 CM
Applicant
TECHNOLOGY DELIVERY SYSTEMS, INC.
1516 thalia street
new orleans, 
LA 
70130

Applicant Contact james harvey knauss
Correspondent
TECHNOLOGY DELIVERY SYSTEMS, INC.
1516 thalia street
new orleans, 
LA 
70130

Correspodent Contact james harvey knauss
Regulation Number 876.1500
Classification Product Code
FGB  
Date Received 05/27/2011
Decision Date 04/04/2012
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