510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771878Substantially Equivalent

Iridium 192 Wires & Pins

Cis Radiopharmaceuticals, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771878 is the FDA 510(k) clearance record for IRIDIUM 192 WIRES & PINS, a class II device, cleared for Cis Radiopharmaceuticals, Inc. on under FDA product code IWA (Source, Wire, Iridium, Radioactive). FDA records list 9 510(k) clearances for Cis Radiopharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K771878.

Clearance record

Decision date
Received
(23 days to decision)
Product code
IWA Source, Wire, Iridium, Radioactive
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Cis Radiopharmaceuticals, Inc. 803 N. Front St. Suite 3, Mchenry IL
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