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

Drainage Catheter With Antibiotic

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

OEI is the FDA product code for Drainage Catheter With Antibiotic, a class II device type, regulated under 21 CFR 878.4780. FDA's definition for this code reads: "A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OEI
Device name
Drainage Catheter With Antibiotic
FDA definition
A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.
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
No
Ingested clearances
1
Ingested recalls
2

Clearances, product code OEI

By decision year
1 clearance under product code OEI with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OEI by decision year
YearClearances
20071

Applicants with the most clearances

Product code OEI
Applicants holding the most 510(k) clearances under product code OEI
ApplicantClearances
Xtant Medical Holdings, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OEI.