The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015.
| Device ID | K091697 |
| 510k Number | K091697 |
| Device Name: | SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TRANSENTERIX, INC. 3908 PATRIOT DRIVE STE 170 Durham, NC 27703 |
| Contact | Tammy Carrea |
| Correspondent | Tammy Carrea TRANSENTERIX, INC. 3908 PATRIOT DRIVE STE 170 Durham, NC 27703 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2009-09-28 |
| Summary: | summary |