K093985 is an FDA 510(k) clearance for the NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE, a Needle, Fistula (Class II — Special Controls, product code FIE), submitted by Nipro Medical Corp. (Doral, US). The FDA issued a Cleared decision on January 22, 2010, 29 days after receiving the submission on December 24, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K093985 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 24, 2009 |
| Decision Date | January 22, 2010 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |