G-PROX EZ ENDOSCOPIC GRASPER


Device Classification Name

endoscopic grasping/cutting instrument, non-powered

510(k) Number K103688
Device Name G-PROX EZ ENDOSCOPIC GRASPER
Applicant
USGI MEDICAL
1140 calle cordillera
san clemente, 
CA 
92673

Applicant Contact mary lou mooney
Correspondent
USGI MEDICAL
1140 calle cordillera
san clemente, 
CA 
92673

Correspodent Contact mary lou mooney
Regulation Number 876.1500
Classification Product Code
OCZ  
Subsequent Product Code
HET  
Date Received 12/17/2010
Decision Date 01/14/2011
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