Single-use Video Scope; PB Digital Controller— 510(k) K254153
Substantially EquivalentMirco-Tech (Nanjing) Co., Ltd.
FDA 510(k) clearance K254153 for Single-use Video Scope; PB Digital Controller, Substantially Equivalent on 2026-04-03. Applicant: Mirco-Tech (Nanjing) Co., Ltd.. Device class: 2.
Summary
Mirco-Tech (Nanjing) Co., Ltd. (the applicant's spelling in the record) lists two devices, a Single-use Video Scope and a PB Digital Controller, under product code FBN (Choledochoscope And Accessories, Flexible/Rigid).
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Mirco-Tech (Nanjing) filed from Nanjing, China. The decision came 102 calendar days after FDA received it (December 22, 2025 to April 3, 2026).
Clearance details
- Applicant
- Mirco-Tech (Nanjing) Co., Ltd.
- Product code
- Product code FBN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nanjing, CN
Recent devices under product code FBN
view all- K253139 — Disposable Distal Cap
- K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more
- K251170 — Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
- K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
- K241444 — Biliary Pancreaticobiliary Scope System
More clearances from Mirco-Tech (Nanjing) Co., Ltd.
view allAdverse events under product code FBN
product code FBN- Death
- 8
- Malfunction
- 951
- Total
- 959
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.