OTK

Wound Drain Catheter System

Product code: OTK
Device name: Wound Drain Catheter System
Device class: Class 2
21 CFR: 21 CFR 878.4780
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (last 3 years): 7

FDA classification definition

For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.

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

Official FDA classification page: OTK

Classification and pathway per current FDA publications. Data from openFDA (CC0).