ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO


Device Classification Name

staple, implantable

510(k) Number K111111
Device Name ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Applicant Contact linda hill
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati, 
OH 
45242

Correspodent Contact linda hill
Regulation Number 878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received 04/20/2011
Decision Date 06/08/2011
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