510(k) K221098 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
| Applicant | Stryker Corporation, Freiburg, DE |
| Decision | Substantially Equivalent, Jul 12, 2022 |
| Received | Apr 14, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221098
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2024 | Stryker Leibinger GmbH & Co. KG 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highl Open, Classified |
PGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.