SPIDER STANDARD AND ADVANCED
FDA 510(k) clearance K102839 · decided 2011-03-15
Clearance details
- K-number
- K102839
- Device name
- SPIDER STANDARD AND ADVANCED
- Applicant
- Transenterix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-29
- Decision date
- 2011-03-15
- Days to decision
- 167 days
- Clearance type
- Special
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SPIDER ADVANCED Surgical Platform The SPIDER is a single port, single incision device to f recall (Z-1910-2011) | Transenterix, Inc | 2011-04-08 |