ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE


Device Classification Name

laparoscopic single port access device

510(k) Number K121309
Device Name ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
Applicant
ADVANCED SURGICAL CONCEPTS
355 thirteenth street, nw
columbia square
washington, 
DC 
20004

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

Correspodent Contact jonathan kahan
Regulation Number 876.1500
Classification Product Code
OTJ  
Date Received 05/01/2012
Decision Date 09/06/2012
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