K130441 is an FDA 510(k) clearance for the FALLER STYLET, a Catheter, Peritoneal, Long-term Indwelling (Class II — Special Controls, product code FJS), submitted by Medionics International, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on April 19, 2013, 57 days after receiving the submission on February 21, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K130441 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 2013 |
| Decision Date | April 19, 2013 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FJS — Catheter, Peritoneal, Long-term Indwelling |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |