K022287 is an FDA 510(k) clearance for the 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by 3t Medical Systems, LLC (Conifer, US). The FDA issued a Cleared decision on September 23, 2002, 70 days after receiving the submission on July 15, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K022287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2002 |
| Decision Date | September 23, 2002 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |