Clearance Summary
Single-use Video Scope; PB Digital Controller received FDA 510(k) clearance under submission number K254153, 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 2026-04-03.
- Submission: K254153
- 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: 2026-04-03
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.