K072594 is an FDA 510(k) clearance for the GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM. This device is classified as a Kit, Nephroscope (Class II - Special Controls, product code FGA).
Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on December 13, 2007, 90 days after receiving the submission on September 14, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K072594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2007 |
| Decision Date | December 13, 2007 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGA — Kit, Nephroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |