Clearance Summary
Disposable Distal Cap received FDA 510(k) clearance under submission number K253139, sponsored by Mirco-Tech (Nanjing) 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 2026-03-19.
- Submission: K253139
- Applicant / Sponsor: Mirco-Tech (Nanjing) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2026-03-19
Classification & Regulation
This clearance is catalogued under FDA product code FBN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.