K001325 is an FDA 510(k) clearance for the FLO ASSISTANT, MODEL 4-250-00. This device is classified as a System, Irrigation, Urological (Class II - Special Controls, product code LJH).
Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on August 18, 2000, 114 days after receiving the submission on April 26, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K001325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2000 |
| Decision Date | August 18, 2000 |
| Days to Decision | 114 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 |