OEI — Drainage Catheter With Antibiotic Class II
FDA product code OEI covers "Drainage Catheter With Antibiotic", a Class II medical device regulated under 21 CFR 878.4780. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OEI
- Device Class
- Class II
- Regulation Number
- 878.4780
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K063245 | bacterin international | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN | November 28, 2007 |