K052286 is an FDA 510(k) clearance for the DEUTSCH ANTI-BLOCKAGE WOUND DRAIN, a Catheter, Irrigation (Class I — General Controls, product code GBX), submitted by The Catheter Exchange, Inc. (Encino, US). The FDA issued a Cleared decision on October 21, 2005, 60 days after receiving the submission on August 22, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K052286 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 22, 2005 |
| Decision Date | October 21, 2005 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |