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. and Clear Catheter Systems.

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
Cleared Nov 30, 2016
PleuraFlow System with FlowGlide
K163139
Clearflow, Inc.
General & Plastic Surgery · 21d
Cleared Jan 20, 2016
PleuraFlow System
K153681
Clearflow, Inc.
General & Plastic Surgery · 29d
Cleared Jun 02, 2015
PleuraFlow System
K150042
Clearflow, Inc.
General & Plastic Surgery · 144d
Cleared Dec 03, 2010
PLEURAFLOW CATHETER SYSTEM
K093565
Clear Catheter Systems
General & Plastic Surgery · 380d

About Product Code OTK - Regulatory Context