PDW

Internal Tissue Marker

Product code

PDW

Device name

Internal Tissue Marker

Device class

Class 2

21 CFR

21 CFR 878.4670

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

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