XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT


Device Classification Name

unit, electrosurgical, endoscopic (with or without accessories)

510(k) Number K030194
Device Name XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
Original Applicant
THE OLYMPUS OPTICAL CO.
endoscope division
two corporate center drive
melville, 
NY 
11747 -3157

Original Contact laura storms-tyler
Regulation Number 876.4300
Classification Product Code
KNS  
Date Received 01/21/2003
Decision Date 03/24/2003
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

Recalls CDRH Recalls