510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922441Substantially Equivalent

Sureseal Bandage

Gainor Medical Europe, Ltd., Long Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922441 is the FDA 510(k) clearance record for SURESEAL BANDAGE, a class I device, cleared for Gainor Medical Europe, Ltd. on under FDA product code KGX (Tape And Bandage, Adhesive). FDA records list 13 510(k) clearances for Gainor Medical Europe, Ltd., from to . As of , FDA records show no recalls naming K922441.

Clearance record

Decision date
Received
(445 days to decision)
Product code
KGX Tape And Bandage, Adhesive
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Gainor Medical Europe, Ltd. 310 Holden Shore, Long Beach CA
510(k) summary
Statement
Third party review
No

Clearances, product code KGX

Trailing 12 months

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

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