# K241168: System 83 Revolve Endoscope Washer/Disinfector

- Pathway: 510(k) (Traditional)
- Applicant: Wassenburg Medical, Inc.
- Decided: Dec 19, 2024 after 237 days
- Product code: FEB (Accessories, Cleaning, For Endoscope)
- 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: 2 generations back to K122172 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173590: System 83 Plus Washer/Disinfector, Custom Ultrasonics, Inc. (2020) Summary page 5.

## Indications for use
The System 83 Revolve® Endoscope Washer/Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the wash/disinfect cycle of the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.

Source page: https://510kreport.com/device/K241168
Methodology: https://510kreport.com/methodology