Product code OTK

Device name

Wound Drain Catheter System

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4780

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset