INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
FDA 510(k) clearance K990188 · decided 1999-04-01
Clearance details
- K-number
- K990188
- Device name
- INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-20
- Decision date
- 1999-04-01
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle recall (Z-1423-05) | Becton Dickinson & Company | 2005-08-30 |