DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
FDA 510(k) clearance K101077 · decided 2011-02-04
Clearance details
- K-number
- K101077
- Device name
- DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-19
- Decision date
- 2011-02-04
- Days to decision
- 291 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for recall (Z-0834-2015) | Intuitive Surgical, Inc. | 2014-12-19 |
| da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, recall (Z-1688-2013) | Intuitive Surgical, Inc. | 2013-07-11 |