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FDA 510(k) clearance · Boston Scientific · Urology

Asurys Fluid Management System

FDA clears Boston Scientific's Asurys irrigation system for endoscopic urologic procedures.

CompareBoston Scientific press release
Cleared · 510(k)

Asurys Fluid Management System

Boston Scientific · Urology

Type
Surgical system
FDA route
510(k) clearance
Used by
Urologists
Bottom line for your practice
45s read

Urologists get one irrigation system across several endoscopic procedures, with automatic inflow regulation tied to intrarenal pressure when used with the LithoVue Elite ureteroscope. The release does not report data showing fewer complications.

What it is
An irrigation management system that provides irrigation and distention during endoscopic urologic procedures. When connected to the LithoVue Elite ureteroscope with intrarenal pressure monitoring, it can automatically regulate irrigation inflow and allows irrigation control from the scope handle.
Indicated for
Patients undergoing endoscopic urologic procedures, including ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures.
What changes
A Boston Scientific executive states that until now no system could automatically respond to intrarenal pressure data in real time, and the on-demand flush is described as replacing manual irrigation. No study or comparison group is described.
Evidence
Design not reportedStudy not named in the releaseThe release gives no study results.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
Watch for
The release contains no clinical data, contraindications or adverse event information for the device. The intrarenal pressure features require pairing with the LithoVue Elite ureteroscope, and the U.S. launch is a limited market release.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
510(k) clearance. Cleared, not approved. The FDA found the device substantially equivalent to one already on the market (its predicate). Clinical trials are often not required.

Clinical summary

The Asurys Fluid Management System provides irrigation and distention during endoscopic urologic procedures, including ureteroscopy, cystoscopy, PCNL and BPH procedures. Paired with the LithoVue Elite ureteroscope, it can automatically regulate irrigation inflow to help keep intrarenal pressure within physician-selected settings. The release reports no clinical study data, and the U.S. launch begins as a limited market release.

From the source 5

Boston Scientific press release

The Boston Scientific press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. MARLBOROUGH, Mass., March 30, 2026 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Asurys™ Fluid Management System, designed to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopies.

    Backs · FDA 510(k) clearance; date 2026-03-30 is the announcement date (the release does not give the FDA decision date)

  2. In addition to ureteroscopies, the Asurys System can be used as an irrigation management option for cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures. Limited market release of the device in the U.S. will begin in the coming days.

    Backs · Procedures covered; limited market release

  3. When paired with the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope with IRP monitoring, the Asurys System is designed to aid in procedural IRP management.11

    Backs · Pairing with LithoVue Elite for intrarenal pressure management

View all 5 lines

  1. "Until now, there has not been a system that can automatically respond to IRP data in real-time. The Asurys Fluid Management System can automatically regulate irrigation inflow to help minimize the potential of exceeding physician-selected IRP settings."

    Backs · Automatic regulation of inflow; no prior system responded automatically to IRP data

  2. By pressing a button on the LithoVue Elite Ureteroscope, physicians can activate the on-demand flush feature to reposition stones into a better location for lithotripsy or basketing without manual irrigation.

    Backs · Scope-handle irrigation control and on-demand flush without manual irrigation

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