K021142 is an FDA 510(k) clearance for the ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Fortune Medical Instrument Corp. (Taipei Hsien, TW). The FDA issued a Cleared decision on October 1, 2002, 175 days after receiving the submission on April 9, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K021142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2002 |
| Decision Date | October 01, 2002 |
| Days to Decision | 175 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 |