K052267 is an FDA 510(k) clearance for the SUPERCATH V. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by Togo Medikit Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on October 27, 2006, 434 days after receiving the submission on August 19, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K052267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2005 |
| Decision Date | October 27, 2006 |
| Days to Decision | 434 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIE - Needle, Fistula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |