K981344 is an FDA 510(k) clearance for the URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING. This device is classified as a Catheter, Nephrostomy.
Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on September 10, 1998, 154 days after receiving the submission on April 9, 1998.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K981344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1998 |
| Decision Date | September 10, 1998 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |