K230632 is an FDA 510(k) clearance for the VersiHD with GuideMe software, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on August 11, 2023, 157 days after receiving the submission on March 7, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K230632 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 2023 |
| Decision Date | August 11, 2023 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5860 |