510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K190843Substantially Equivalent

Synchro2 Support Guidewire

Stryker Corp., Fremont CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190843 is the FDA 510(k) clearance record for Synchro2 Support Guidewire, a class II device, cleared for Stryker on under FDA product code MOF (Guide, Wire, Catheter, Neurovasculature). FDA records list 568 510(k) clearances for Stryker, from to . As of , FDA records show 8 recalls naming K190843.

Clearance record

Decision date
Received
(30 days to decision)
Product code
MOF Guide, Wire, Catheter, Neurovasculature
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Stryker 47900 Bayside Pkwy., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOF

Trailing 12 months
12 clearances under product code MOF in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20262
April 20262
May 20260
June 20260
July 20261
August 20263
September 20261
October 20260