Cleared Special

Synchro SELECT Guidewire

K202522 · Stryker Neurovascular · Neurology
Sep 2020
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K202522 is an FDA 510(k) clearance for the Synchro SELECT Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on September 25, 2020, 24 days after receiving the submission on September 1, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K202522 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2020
Decision Date September 25, 2020
Days to Decision 24 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MOF — Guide, Wire, Catheter, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330