KKX

Drape, Surgical, Antimicrobial

Product code

KKX

Device name

Drape, Surgical, Antimicrobial

Device class

Class 2

21 CFR

21 CFR 878.4370

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

450 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-10-25.