The following data is part of a premarket notification filed by Ncontact Surgical, Inc. with the FDA for Numeris Coagulation System With Visitrax, Model(s) Csk-021;csk-022; Csk-023; Csk-025.
| Device ID | K082203 |
| 510k Number | K082203 |
| Device Name: | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | NCONTACT SURGICAL, INC. 1001 AVIATION PARKWAY, SUITE 400 Morrisville, NC 27560 |
| Contact | Jane Ricupero |
| Correspondent | Jane Ricupero NCONTACT SURGICAL, INC. 1001 AVIATION PARKWAY, SUITE 400 Morrisville, NC 27560 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-05 |
| Decision Date | 2008-12-30 |
| Summary: | summary |