ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL


Device Classification Name

staple, implantable

510(k) Number K112056
Device Name ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Applicant Contact asifa vonhof
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Correspodent Contact asifa vonhof
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 07/19/2011
Decision Date 12/19/2011
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

Recalls CDRH Recalls