510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970441Substantially Equivalent

K-Klosure 2 Inch Length/4 Inch Length/8 Inch Length/12 Inch Length

Medi-Flex Hospital Products, Inc., Overland Park KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970441 is the FDA 510(k) clearance record for K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH, a class I device, cleared for Medi-Flex Hospital Products, Inc. on under FDA product code FPX (Strip, Adhesive, Closure, Skin). FDA records list 13 510(k) clearances for Medi-Flex Hospital Products, Inc., from to . As of , FDA records show no recalls naming K970441.

Clearance record

Decision date
Received
(93 days to decision)
Product code
FPX Strip, Adhesive, Closure, Skin
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Medi-Flex Hospital Products, Inc. 8717 W. 110th St., Suite 750, Overland Park KS
510(k) summary
Statement
Third party review
No

Clearances, product code FPX

Trailing 12 months

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

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