Device Classification Name |
System, Surgical, Computer Controlled Instrument
|
510(k) Number |
K141077 |
Device Name |
DA VINCI FIREFLY IMAGING SYSTEM |
Applicant |
INTUITIVE SURGICAL, INC. |
1266 KIFER RD |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
MELISSA S GONZALEZ |
Correspondent |
INTUITIVE SURGICAL, INC. |
1266 KIFER RD |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
MELISSA S GONZALEZ |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/25/2014 |
Decision Date | 08/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|