K063245 is an FDA 510(k) clearance for the ELUTIA COATED CLOSED SURGICAL WOUND DRAIN. This device is classified as a Drainage Catheter With Antibiotic (Class II - Special Controls, product code OEI).
Submitted by Bacterin International, Inc. (Shelton, US). The FDA issued a Cleared decision on November 28, 2007, 398 days after receiving the submission on October 26, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780. 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) Number | K063245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2006 |
| Decision Date | November 28, 2007 |
| Days to Decision | 398 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OEI — Drainage Catheter With Antibiotic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |
| 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. |