Synchro SELECT Guidewire— 510(k) K202522

Clearance details

Applicant

Stryker Neurovascular

Product code

Code MOF

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2020-09-01

Decision date

2020-09-25

Decision

Substantially Equivalent

Clearance type

Special

Location

Fremont, CA, US

• K260751 — 35 Helix Guidewire2026-08-27
• K262424 — Willow 12 Guidewire2026-08-14
• K260223 — Aristotle Mini Guidewire2026-08-06
• K254006 — Drivewire 35 Guidewire2026-07-17
• K253579 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire2026-04-29

• K261889 — Trevo Trak 21 Microcatheter2026-07-01
• K253032 — AXS Lift Intracranial Base Catheter2026-02-11
• K252694 — Target Detachable Coil2025-12-11
• K251832 — InZone IST Detachment System; IZDS Connecting Cable2025-10-17
• K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter2025-03-21

Death

6

Injury

137

Total

143

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-1940-2024 — The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.Class II·Ongoing·Stryker Neurovascular·20240418

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202522.