K023162 is an FDA 510(k) clearance for the FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by Fresenius Medical Care (Lexington, US). The FDA issued a Cleared decision on March 20, 2003, 178 days after receiving the submission on September 23, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K023162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2002 |
| Decision Date | March 20, 2003 |
| Days to Decision | 178 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 |