Clearance Summary
Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 received FDA 510(k) clearance under submission number K243371, sponsored by Byonyks Pvt, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-05-16.
- Submission: K243371
- Applicant / Sponsor: Byonyks Pvt, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2025-05-16
Classification & Regulation
This clearance is catalogued under FDA product code FKX and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.