PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)— 510(k) K141551

Clearance details

Applicant

Stryker Corporate

Product code

Code PGW

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2014-06-11

Decision date

2014-09-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kalamazoo, MI, US

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Malfunction

1,199

Total

1,199

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2071-2017 — 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-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20170310

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141551.