ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER


Device Classification Name

staple, implantable

510(k) Number K110385
Device Name ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
Applicant
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati, 
OH 
45242 -2839

Applicant Contact asifa vonhof
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati, 
OH 
45242 -2839

Correspodent Contact asifa vonhof
Regulation Number 878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received 02/10/2011
Decision Date 03/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No