510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042893Substantially Equivalent

Under Buttocks Drape

Intl. Medsurg Connection, Inc., Cudahy WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042893 is the FDA 510(k) clearance record for UNDER BUTTOCKS DRAPE, a class II device, cleared for International Medsurg Connection, Inc. 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 15 510(k) clearances for INTL. MEDSURG CONNECTION, INC., from to . As of , FDA records show no recalls naming K042893.

Clearance record

Decision date
Received
(143 days to decision)
Product code
KKX Drape, Surgical, Antimicrobial
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
International Medsurg Connection, Inc. P.O. Box 100624, Cudahy WI
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