ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)


Device Classification Name

staple, implantable

510(k) Number K081146
Device Name ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Applicant Contact abhilasha mukherjee
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Correspodent Contact abhilasha mukherjee
Regulation Number 878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received 04/22/2008
Decision Date 06/26/2008
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