Drainage Catheter With Antibiotic
The Drainage Catheter with Antibiotic (product code OEI) is a general and plastic surgery device consisting of a tubular drain made from silicone or similar material, coated with a silver-containing antimicrobial material, intended to drain fluids from body cavities using gravity drainage or suction, while the antimicrobial coating helps reduce the risk of catheter-related infection. This device is FDA Class 2 under regulation 878.4780 in the General, Plastic Surgery specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OEI
- Device Class
- FDA class 2
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K063245 | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN | Nov 28, 2007 | Substantially Equivalent | Bacterin International, Inc. |