510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843400Substantially Equivalent

Hydro-Splint a Sponge-Compress Dress

Compression Splint Products, Inc., Pittsburgh P / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843400 is the FDA 510(k) clearance record for HYDRO-SPLINT A SPONGE-COMPRESS DRESS, a class I device, cleared for Compression Splint Products, Inc. on under FDA product code FYH (Splint, Extremity, Noninflatable, External, Sterile). FDA records list one 510(k) clearance for Compression Splint Products, Inc. As of , FDA records show no recalls naming K843400.

Clearance record

Decision date
Received
(55 days to decision)
Product code
FYH Splint, Extremity, Noninflatable, External, Sterile
Regulation
21 CFR 878.3910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Compression Splint Products, Inc. P.O. Box 7407, Pittsburgh P
Third party review
No

Clearances, product code FYH

Trailing 12 months

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

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