DeviceClearance

Product code OTK— General, Plastic Surgery

PleuraFlow System

Classification name
Wound Drain Catheter System
Device class
Class 2
Regulation
21 CFR 878.4780
Advisory panel
General, Plastic Surgery
Total cleared
7
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OTK under 21 CFR 878.4780, via openFDA

Market context for product code OTK

FDA has cleared 7 devices under product code OTK between 2010 and 2021, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OTK

Recent clearances under product code OTK

Data sourced from openFDA. This site is unofficial and independent of the FDA.