Clearance Summary
WellCare Anoscope received FDA 510(k) clearance under submission number K230439, sponsored by Well Care (Wuhan) Medical Technology Co., 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 2023-12-22.
- Submission: K230439
- Applicant / Sponsor: Well Care (Wuhan) Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-12-22
Classification & Regulation
This clearance is catalogued under FDA product code FER and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.