5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT


Device Classification Name

system,surgical,computer controlled instrument

510(k) Number K112584
Device Name 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
Applicant
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale, 
CA 
94086 -5206

Applicant Contact kim t servance
Correspondent
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale, 
CA 
94086 -5206

Correspodent Contact kim t servance
Regulation Number 876.1500
Classification Product Code
NAY  
Date Received 09/06/2011
Decision Date 09/29/2011
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