K071832 is an FDA 510(k) clearance for the MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM. This device is classified as 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 September 18, 2007, 77 days after receiving the submission on July 3, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K071832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2007 |
| Decision Date | September 18, 2007 |
| Days to Decision | 77 days |
| Submission Type | Special |
| 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 |