# K221784: Single-use Video Pancreaticobiliary Scope, PB Digital Controller

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Feb 16, 2023 after 240 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: 11 generations back to K931154 (1993). 48 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142922: SpyGlass DS Direct Visualization System, Boston Scientific Corporation (2015) Summary page 5.
- K200483: SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller, Boston Scientific Corporation (2020) Summary page 5.

## Most influential descendants
- K252492: Visualized Access and Delivery Catheter; PB Digital Controller (2026), 0 descendants of its own
- K254153: Single-use Video Scope; PB Digital Controller (2026), 0 descendants of its own

## Indications for use
The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope. The Single-use Video Pancreaticobiliary 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. The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.

Source page: https://510kreport.com/device/K221784
Methodology: https://510kreport.com/methodology