# K251273: Asurys Fluid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 27, 2026 after 337 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K873435 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172048: FluidSmart, Thermedx, LLC (2017) Summary page 5.

## Indications for use
The Asurys™ Fluid Management System is intended for use in conjunction with an endoscope to provide irrigation and distention within endourological procedures.

Source page: https://510kreport.com/device/K251273
Methodology: https://510kreport.com/methodology