K132383 is an FDA 510(k) clearance for the GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER. This device is classified as a Catheter, Nephrostomy.
Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on February 4, 2014, 188 days after receiving the submission on July 31, 2013.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K132383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2013 |
| Decision Date | February 04, 2014 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |