K162992 is an FDA 510(k) clearance for the Karl Storz UROMAT E.A.S.I.. This device is classified as a System, Irrigation, Urological (Class II - Special Controls, product code LJH).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on July 7, 2017, 253 days after receiving the submission on October 27, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K162992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2016 |
| Decision Date | July 07, 2017 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJH — System, Irrigation, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |