510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850163Substantially Equivalent

Iridium 192 Wires

Syncor Intl. Corp., Sylmar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850163 is the FDA 510(k) clearance record for IRIDIUM 192 WIRES, a class II device, cleared for Syncor Intl. Corp. on under FDA product code IWA (Source, Wire, Iridium, Radioactive). FDA records list 31 510(k) clearances for Syncor Intl. Corp., from to . As of , FDA records show no recalls naming K850163.

Clearance record

Decision date
Received
(69 days to decision)
Product code
IWA Source, Wire, Iridium, Radioactive
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Syncor Intl. Corp. 12847 Arroyo St., Sylmar CA
Third party review
No

Clearances, product code IWA

Trailing 12 months

FDA records hold no clearances under product code IWA in the trailing twelve months.

FDA records show no clearances under product code IWA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260