ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE


Device Classification Name

laparoscopic single port access device

510(k) Number K110004
Device Name ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
Applicant
ADVANCED SURGICAL CONCEPTS
355 thirteenth street, nw
washington, 
DC 
20004

Applicant Contact jonathan kahan
Correspondent
ADVANCED SURGICAL CONCEPTS
355 thirteenth street, nw
washington, 
DC 
20004

Correspodent Contact jonathan kahan
Regulation Number 876.1500
Classification Product Code
OTJ  
Subsequent Product Code
GCJ  
Date Received 01/03/2011
Decision Date 01/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No