# K233779: LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)

- Pathway: 510(k) (Traditional)
- Applicant: MacroLux Medical Technology Co., Ltd.
- Decided: Apr 5, 2024 after 130 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921244 (1992). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173727: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor, Ambu A/S (2018)

## Indications for use
The LoopView® is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree. The endoscope is intended to provide visualization via MACROLUX™ video processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults. The ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.

Source page: https://510kreport.com/device/K233779
Methodology: https://510kreport.com/methodology