TRIPORT, TRIPORT+, TRIPORT15, QUADPORT


Device Classification Name

laparoscopic single port access device

510(k) Number K111407
Device Name TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
Applicant
ADVANCED SURGICAL CONCEPTS
355 thirteenth street, nw
washington, 
DC 
20004

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

Correspodent Contact jonathan s kahan
Regulation Number 876.1500
Classification Product Code
OTJ  
Date Received 05/19/2011
Decision Date 01/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No