SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000


Device Classification Name

insufflator, laparoscopic

510(k) Number K103692
Device Name SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
Applicant
SURGIQUEST, INC.
12 cascade blvd.
suite 2b
orange, 
CT 
06477

Applicant Contact daniel donovan
Correspondent
SURGIQUEST, INC.
12 cascade blvd.
suite 2b
orange, 
CT 
06477

Correspodent Contact daniel donovan
Regulation Number 884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received 12/17/2010
Decision Date 05/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No