K063700 is an FDA 510(k) clearance for the SPYGLASS IRRIGATION SYSTEM, a System, Irrigation, Urological (Class II — Special Controls, product code LJH), submitted by Medical Scientific, Inc. (Taunton, US). The FDA issued a Cleared decision on February 8, 2007, 57 days after receiving the submission on December 13, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K063700 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 13, 2006 |
| Decision Date | February 08, 2007 |
| Days to Decision | 57 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 |