# K252492: Visualized Access and Delivery Catheter; PB Digital Controller

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Apr 24, 2026 after 259 days
- Product code: SHU (Appendiceal Scope And Accessories, Flexible)
- 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.

## Indications for use
Visualized Access and Delivery Catheter: The Visualized Access and Delivery Catheter have beien designed to be used with the PB Digital Controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of vermiform appendix, and provide working channel for other diagnosis and treatment accessories. The Visualized Access and Delivery Catheter is to be used with a colonoscope for appendicitis diagnosis and treatment procedures under direct visualization in adults, adolescents, and children. 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/K252492
Methodology: https://510kreport.com/methodology