The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical Instruments, Flexible Monopolar.
| Device ID | K122299 |
| 510k Number | K122299 |
| Device Name: | SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TRANSENTERIX, INC. 635 DAVIS DRIVE SUITE 300 Durham, NC 27713 |
| Contact | Tammy B Carrea |
| Correspondent | Tammy B Carrea TRANSENTERIX, INC. 635 DAVIS DRIVE SUITE 300 Durham, NC 27713 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-31 |
| Decision Date | 2012-10-25 |
| Summary: | summary |