Model FUS-1 Flexible Ureteroscope

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K811535 ↗

FDA Product Code

FGB

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Model FUS-1 Flexible Ureteroscope used for?

  The Model FUS-1 Flexible Ureteroscope is designed for visualizing and accessing the ureter and renal pelvis, primarily used in urological procedures to diagnose and treat conditions such as stones or obstructions within the urinary tract.

• Is the Model FUS-1 Flexible Ureteroscope a single-use device?

  No, the Model FUS-1 Flexible Ureteroscope is supplied as a reusable medical instrument intended for multiple uses in clinical settings including operating rooms and outpatient procedures.

• What regulatory pathway was used for the Model FUS-1 Flexible Ureteroscope?

  The device was cleared under the FDA's 510(k) pathway in 1981 (K811535) as substantially equivalent to predicate devices, with a decision code of SESE indicating substantial equivalence.

• What classification code applies to the Model FUS-1 Flexible Ureteroscope?

  The device is classified under product code FGB and device class 2, which is standard for reusable ureteroscopes and their accessories used in urological procedures.

• Is there any information about sterility or MRI safety for this device?

  No specific sterility or MRI safety information is provided in the device data, so clinicians should consult the manufacturer for details on these aspects.