CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX


Device Classification Name

unit, electrosurgical, endoscopic (with or without accessories)

510(k) Number K080946
Device Name CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
Applicant
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
129 concord rd.
billerica, 
MA 
01821

Applicant Contact beth zis
Regulation Number 876.4300
Classification Product Code
KNS  
Date Received 04/03/2008
Decision Date 05/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No