510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K923607Substantially Equivalent

Radifocus Guide Wire M

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923607 is the FDA 510(k) clearance record for RADIFOCUS GUIDE WIRE M, a class II device, cleared for Terumo Medical Corp. on under FDA product code KOD (Catheter, Urological). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K923607.

Clearance record

Decision date
Received
(78 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Terumo Medical Corp. P.O. Box 605, Elkton MD
510(k) summary
Summary
Third party review
No

Clearances, product code KOD

Trailing 12 months
1 clearance under product code KOD in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260