Metal Ureteral Basket Stone Dislodger

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

510(k) Number

K934675 ↗

FDA Product Code

FFL

Device Class

Class II

Regulation

21 CFR Part 876.4680

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Metal Ureteral Basket Stone Dislodger

  Class II

  FDA 510(k) K951532 Active Cleared 19 Jul 1995

• Cytology Brush (FDX)

  Class II

  FDA 510(k) K913248 Active Cleared 30 Sep 1991

• Biopsy Forceps

  Class II

  FDA 510(k) K895098 Active Cleared 30 Oct 1989

• Flexible Snare

  Class II

  FDA 510(k) K902265 Active Cleared 27 Jul 1990

• Grasping Forceps or Retrieval Forceps

  Class II

  FDA 510(k) K934598 Active Cleared 7 Jan 1994

• Biliary Stone Dislodger LQR

  Class II

  FDA 510(k) K925559 Active Cleared 17 Dec 1992

See all devices from Annex Medical, Inc. →

• What is the primary purpose of the Metal Ureteral Basket Stone Dislodger in clinical practice?

  The Metal Ureteral Basket Stone Dislodger is designed to entrap and remove ureteral stones during endoscopic procedures. It is inserted through a cystoscope to help relieve obstruction or pain caused by calculi in the ureter, making it useful for urological and gastroenterological settings.

• Is this device reusable, or is it intended for single-use only?

  This device is explicitly intended for single-use applications. It is supplied sterile and does not require additional sterilization, ensuring safety and compliance with medical best practices.

• What precautions should be taken when handling or using this device due to its construction?

  The device contains metal components, which means it is MRI-unsafe and must be handled with care to avoid damage. Clinicians should ensure it is not exposed to MRI environments and store it properly to maintain its integrity.

• How many sizes or configurations are available for this device, and how can I determine the correct one for my patient?

  The device is available in various sizes and configurations, as indicated by the multiple registration numbers (e.g., 3011193403, 3012649202, etc.). The correct size should be selected based on clinical assessment, stone size, and procedural requirements—consult the manufacturer’s sizing guidelines or your urology team for specific recommendations.

• What regulatory pathway does this device follow, and how does that affect its use in clinical practice?

  The Metal Ureteral Basket Stone Dislodger is regulated under the FDA 510(k) clearance process (K934675) and classified as a Class II medical device under the FFL product code. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring its safety and effectiveness for its intended single-use purpose in stone retrieval procedures.