The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003.
| Device ID | K090902 |
| 510k Number | K090902 |
| Device Name: | SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TRANSENTERIX, INC. 3908 PATRIOT DRIVE STE 170 Durham, NC 27540 |
| Contact | Tammy Carrea |
| Correspondent | Tammy Carrea TRANSENTERIX, INC. 3908 PATRIOT DRIVE STE 170 Durham, NC 27540 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-07-22 |
| Summary: | summary |