SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE


Device Classification Name

endoscope and/or accessories

510(k) Number K023902
Device Name SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
Original Applicant
USGI MEDICAL, INC.
2 delphinus
irvine, 
CA 
92612

Original Contact judy f gordon
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 11/22/2002
Decision Date 08/20/2003
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