K191563 is an FDA 510(k) clearance for the FILTRAY 2G Disposable Water Filters. This device is classified as a System, Water Purification, General Medical Use (Class II - Special Controls, product code NHV).
Submitted by Aqua-Tools (Poissy, FR). The FDA issued a Cleared decision on October 25, 2019, 134 days after receiving the submission on June 13, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665. The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing..
| 510(k) Number | K191563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2019 |
| Decision Date | October 25, 2019 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NHV - System, Water Purification, General Medical Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |
| Definition | The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing. |