510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831764Substantially Equivalent

Urias Pressure Splints, & First Aid

Svenol Andersen, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831764 is the FDA 510(k) clearance record for URIAS PRESSURE SPLINTS, & FIRST AID, a class I device, cleared for Svenol Andersen on under FDA product code FZF (Splint, Extremity, Inflatable, External). FDA records list one 510(k) clearance for Svenol Andersen. As of , FDA records show no recalls naming K831764.

Clearance record

Decision date
Received
(103 days to decision)
Product code
FZF Splint, Extremity, Inflatable, External
Regulation
21 CFR 878.3900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Svenol Andersen 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FZF

Trailing 12 months

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

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