510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864111Substantially Equivalent

Sterile Field #605 Fenestrated Sterile Field #606

Graham Medical Products, Holyoke MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864111 is the FDA 510(k) clearance record for STERILE FIELD #605 FENESTRATED STERILE FIELD #606, a class II device, cleared for Graham Medical Products 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 9 510(k) clearances for Graham Medical Products, from to . As of , FDA records show no recalls naming K864111.

Clearance record

Decision date
Received
(9 days to decision)
Product code
KKX Drape, Surgical, Antimicrobial
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Graham Medical Products P.O. Box 510, 56 Canal St., Holyoke MA
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