510(k) K141551 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
| Applicant | Stryker Corporate, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Sep 8, 2014 |
| Received | Jun 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141551
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2017 | Stryker Instruments Div. of Stryker Corporation Stryker PROFESS Registration Kit.
The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer- Terminated |
PGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.