K122952 is an FDA 510(k) clearance for the NIPRO PUREFLUX-L HEMODIALYZER, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Nipro Medical Corporation (Suwanee, US). The FDA issued a Cleared decision on December 4, 2013, 435 days after receiving the submission on September 25, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K122952 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2012 |
| Decision Date | December 04, 2013 |
| Days to Decision | 435 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJI — Dialyzer, Capillary, Hollow Fiber |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |