The following data is part of a premarket notification filed by Stryker Ent with the FDA for Tgs Guidewire And Updated Scopis Software.
| Device ID | K193118 |
| 510k Number | K193118 |
| Device Name: | TGS Guidewire And Updated Scopis Software |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-02-21 |