510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900822Substantially Equivalent

Hydro-Sil(tm) Coated Guidewires

National-Standard Medical Products, Gainesville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900822 is the FDA 510(k) clearance record for HYDRO-SIL(TM) COATED GUIDEWIRES, a class II device, cleared for National-Standard Medical Products on under FDA product code DOX (Fluorometer, Lead (Dedicated Instruments)). FDA records list 3 510(k) clearances for National-Standard Medical Products, from to . As of , FDA records show no recalls naming K900822.

Clearance record

Decision date
Received
(146 days to decision)
Product code
DOX Fluorometer, Lead (Dedicated Instruments)
Regulation
21 CFR 862.3550
Device class
Class II
Review panel
Clinical Toxicology
Applicant
National-Standard Medical Products 4445-360 SW 35th Ter., Gainesville FL
Third party review
No

Clearances, product code DOX

Trailing 12 months

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

FDA records show no clearances under product code DOX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DOX, 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