OVERTUBE ENDOSCOPIC ACCESS SYSTEM


Device Classification Name

endoscopic access overtube, gastroenterology-urology

510(k) Number K122270
Device Name OVERTUBE ENDOSCOPIC ACCESS SYSTEM
Applicant
APOLLO ENDOSURGERY, INC.
7000 bee caves rd. suite 350
austin, 
TX 
78746

Applicant Contact heather crawford, rac
Correspondent
APOLLO ENDOSURGERY, INC.
7000 bee caves rd. suite 350
austin, 
TX 
78746

Correspodent Contact heather crawford, rac
Regulation Number 876.1500
Classification Product Code
FED  
Date Received 07/30/2012
Decision Date 09/28/2012
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