The following data is part of a premarket notification filed by Ncontact Surgical, Inc. with the FDA for Epi-sense Guided Coagulation Device With Visitrax.
| Device ID | K120857 |
| 510k Number | K120857 |
| Device Name: | EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | NCONTACT SURGICAL, INC. 1001 AVIATION PARKWAY STE 400 Morrisville, NC 27560 |
| Contact | Jane Ricupero |
| Correspondent | Jane Ricupero NCONTACT SURGICAL, INC. 1001 AVIATION PARKWAY STE 400 Morrisville, NC 27560 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-21 |
| Decision Date | 2012-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30840143900338 | K120857 | 000 |
| 30840143900291 | K120857 | 000 |
| 10840143904554 | K120857 | 000 |
| 30840143903810 | K120857 | 000 |