K243371
- 510(k) number
- K243371
- Device name
- Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
- Applicant
- Byonyks Pvt, Ltd. PK
- Product code
- FKX — System, Peritoneal, Automatic Delivery
- Decision date
- 2025-05-16
- Date received
- 2024-10-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243371.pdf
Official FDA record: K243371
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.