K072988 is an FDA 510(k) clearance for the NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1. This device is classified as a Protector, Transducer, Dialysis (Class II - Special Controls, product code FIB).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on February 21, 2008, 121 days after receiving the submission on October 23, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K072988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2007 |
| Decision Date | February 21, 2008 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIB — Protector, Transducer, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |