The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Spider Flexible Blunt Dissector And Band Passer.
Device ID | K120403 |
510k Number | K120403 |
Device Name: | SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | TRANSENTERIX, INC. 635 DAVIS DRIVE SUITE 300 Durham, NC 27560 |
Contact | Tammy B Carrea |
Correspondent | Tammy B Carrea TRANSENTERIX, INC. 635 DAVIS DRIVE SUITE 300 Durham, NC 27560 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-09 |
Decision Date | 2012-04-16 |
Summary: | summary |