The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Spider Standard And Advanced.
| Device ID | K102839 |
| 510k Number | K102839 |
| Device Name: | SPIDER STANDARD AND ADVANCED |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TRANSENTERIX, INC. 635 DAVIS DRIVE SUITE 300 Morrisville, NC 27560 |
| Contact | Bobbi L Hadersbeck |
| Correspondent | Bobbi L Hadersbeck TRANSENTERIX, INC. 635 DAVIS DRIVE SUITE 300 Morrisville, NC 27560 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-03-15 |
| Summary: | summary |