510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K923358Substantially Equivalent

Lc Strip

Genetic Laboratories Wound Care, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923358 is the FDA 510(k) clearance record for LC STRIP, a class I device, cleared for Genetic Laboratories Wound Care, Inc. on under FDA product code KGX (Tape And Bandage, Adhesive). FDA records list one 510(k) clearance for Genetic Laboratories Wound Care, Inc. As of , FDA records show no recalls naming K923358.

Clearance record

Decision date
Received
(189 days to decision)
Product code
KGX Tape And Bandage, Adhesive
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Genetic Laboratories Wound Care, Inc. 2726 Patton Rd., St. Paul MN
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