VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS


Device Classification Name

staple, implantable

510(k) Number K111195
Device Name VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
Applicant
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati, 
OH 
45242 -2839

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

Correspodent Contact dennis hahn
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 04/28/2011
Decision Date 08/03/2011
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