SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
FDA 510(k) clearance K091697 · decided 2009-09-28
Clearance details
- K-number
- K091697
- Device name
- SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
- Applicant
- Transenterix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-10
- Decision date
- 2009-09-28
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are inte recall (Z-2137-2012) | Transenterix, Inc | 2012-08-03 |
| Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC recall (Z-2465-2010) | Transenterix, INC | 2010-09-22 |