PUI

Drape, Surgical, Exempt

Product code

PUI

Device name

Drape, Surgical, Exempt

Device class

Class 2

21 CFR

21 CFR 878.4370

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K) Exempt

FDA classification definition

This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

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