# K254153: Single-use Video Scope; PB Digital Controller

- Pathway: 510(k) (Traditional)
- Applicant: Mirco-Tech (Nanjing) Co., Ltd.
- Decided: Apr 3, 2026 after 102 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K931154 (1993). 49 ancestors in all.
No later device cites it as a predicate yet.
2 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221784: Single-use Video Pancreaticobiliary Scope, PB Digital Controller, Micro-Tech (Nanjing) Co., Ltd. (2023) Summary page 5.
- K142922: SpyGlass DS Direct Visualization System, Boston Scientific Corporation (2015) Summary page 5.

## Indications for use
Single-use Video Scope:The Single-use Video Scope is used in combination with the PB Digital Controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories. PB Digital Controller: The PB Digital Controller can be used together with the endoscope to process the image collected by the endoscope and transmit it to the display.

Source page: https://510kreport.com/device/K254153
Methodology: https://510kreport.com/methodology