SURGICAL TISSUE MANAGEMENT SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K111202
Device Name SURGICAL TISSUE MANAGEMENT SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate parkway
center valley, 
PA 
18034 -0610

Applicant Contact stacy a kluesner, m.s., rac
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate parkway
center valley, 
PA 
18034 -0610

Correspodent Contact stacy a kluesner, m.s., rac
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Codes
KNS   LFL  
Date Received 04/29/2011
Decision Date 01/20/2012
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