The following data is part of a premarket notification filed by Gauthier Biomedical, Inc. with the FDA for Intellitorq.
| Device ID | K180092 |
| 510k Number | K180092 |
| Device Name: | Intellitorq |
| Classification | Wrench |
| Applicant | Gauthier Biomedical, Inc. 2221 Washington St. Grafton, WI 53024 |
| Contact | Austin Braganza |
| Correspondent | Austin Braganza Gauthier Biomedical, Inc. 2221 Washington St. Grafton, WI 53024 |
| Product Code | HXC |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-12 |
| Decision Date | 2018-03-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INTELLITORQ 85843876 4614501 Live/Registered |
Gauthier Biomedical, Inc. 2013-02-07 |