OTK · Class II · 21 CFR 878.4780

FDA Product Code OTK: Wound Drain Catheter System

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.

Leading manufacturers include Clearflow, Inc..

7
Total
7
Cleared
103d
Avg days
2010
Since

FDA 510(k) Cleared Wound Drain Catheter System Devices (Product Code OTK)

7 devices
1–7 of 7
Cleared Mar 02, 2021
PleuraFlow System with FlowGlide
K203394
Clearflow, Inc.
General & Plastic Surgery · 104d
Cleared Jul 26, 2019
The ZIP Accessory Shuttle for PleuraFlow System
K191733
Clearflow, Inc.
General & Plastic Surgery · 28d
Cleared Aug 14, 2018
PleuraFlow System with FlowGlide Extra Drainage Length
K182067
Clearflow, Inc.
General & Plastic Surgery · 13d

About Product Code OTK - Regulatory Context