GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM


Device Classification Name

kit, nephroscope

510(k) Number K072594
Device Name GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
Applicant
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Applicant Contact graham a baillie
Correspondent
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Correspodent Contact graham a baillie
Regulation Number 876.1500
Classification Product Code
FGA  
Subsequent Product Codes
FEC   FED  
Date Received 09/14/2007
Decision Date 12/13/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No