510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130404Substantially Equivalent

Tiburon Surgical Drape

Cardinal Health200, LLC, Waukegan IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130404 is the FDA 510(k) clearance record for TIBURON SURGICAL DRAPE, a class II device, cleared for Cardinal Health200, LLC on under FDA product code KKX (Drape, Surgical, Antimicrobial). FDA's definition for product code KKX reads: "Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI". FDA records list 26 510(k) clearances for Cardinal Health200, LLC, from to . As of , FDA records show no recalls naming K130404.

Clearance record

Decision date
Received
(136 days to decision)
Product code
KKX Drape, Surgical, Antimicrobial
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cardinal Health200, LLC 1430 Waukegan Rd., Waukegan IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KKX

Trailing 12 months

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

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