510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OTKClass II

Wound Drain Catheter System

21 CFR 878.4780 / General, Plastic Surgery
FDA source (opens on fda.gov)

OTK is the FDA product code for Wound Drain Catheter System, a class II device type, regulated under 21 CFR 878.4780. FDA's definition for this code reads: "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". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OTK
Device name
Wound Drain Catheter System
FDA 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.
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
7
Ingested recalls
0

Clearances, product code OTK

By decision year
7 clearances under product code OTK with a decision year between 2010 and 2021, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OTK by decision year
YearClearances
20101
20151
20162
20181
20191
20211

Applicants with the most clearances

Product code OTK
Applicants holding the most 510(k) clearances under product code OTK
ApplicantClearances
Clearflow, Inc6
Clear Catheter Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code