ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING


information about

Device Classification Name

endoscope and/or accessories

510(k) Number K002398
Device Name ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
Original Applicant
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati, 
OH 
45242 -2839

Original Contact edwin o billips
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 08/07/2000
Decision Date 11/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No