# K193202: EXALT Model D Single-Use Duodenoscope, EXALT Controller

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Dec 13, 2019 after 23 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 33 ancestors in all.
4 later devices descend from it; 1 cites it directly.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143153: Evis Exera II Duodenovideoscope Olympus TJF Type Q180V, Olympus Medical Systems Corp. (2016) Summary page 5.
- K122831: Video System Center, Olympus Medical Systems Corp. (2012) Summary page 5.

## Most influential descendants
- K213606: EvoEndo Single-Use Endoscopy System (2022), 3 descendants of its own
- K251708: EvoEndo Single-Use Endoscopy System (2025), 1 descendant of its own
- K260573: EvoEndo Single-Use Endoscopy System (2026), 0 descendants of its own
- K250900: EvoEndo Single-Use Endoscopy System (2025), 0 descendants of its own

## Recalls of this device
- Sep 27, 2023 · Class II · Z-0396-2024: Poor image quality due to fluid ingress in the lens.
- Sep 27, 2023 · Class II · Z-0397-2024: Poor image quality due to fluid ingress in the lens.
- Mar 3, 2022 · Class II · Z-1081-2022: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal 
- Mar 3, 2022 · Class II · Z-1079-2022: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal 
- Mar 3, 2022 · Class II · Z-1080-2022: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal 
- Mar 3, 2022 · Class II · Z-1082-2022: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal 

## Indications for use
The EXALT Model D Single-Use Duodenoscope is intended for use with a Boston Scientific endoscopic video imaging system, for endoscopy and endoscopic surgery within the duodenum. The EXALT Controller is intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation.

Source page: https://510kreport.com/device/K193202
Methodology: https://510kreport.com/methodology