Biliary Stone Dislodger LQR

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Biliary Stone Dislodger

510(k) Number

K925559 ↗

FDA Product Code

LQR

Device Class

Class II

Regulation

21 CFR Part 876.5010

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

• Forceps, Grasping, Flexible Endoscopic

  Class II

  FDA 510(k) K954377 Active Cleared 26 Oct 1995

See all devices from Annex Medical, Inc. →

• What types of medical professionals typically use the Biliary Stone Dislodger LQR, and where are these procedures performed?

  The Biliary Stone Dislodger LQR is primarily used by gastroenterologists and urologists. These procedures are performed in clinical settings such as endoscopy suites or operating rooms, where the device assists in the mechanical fragmentation or dislodgment of gallstones during endoscopic or surgical interventions.

• Is the Biliary Stone Dislodger LQR a single-use or reusable device, and what sterilization requirements apply?

  The Biliary Stone Dislodger LQR is designed as a reusable instrument. After each use, it must undergo proper sterilization to ensure safety and prevent cross-contamination between patients, adhering to standard medical device sterilization protocols.

• How do I determine the correct size or model of the Biliary Stone Dislodger LQR for my clinical needs?

  The device data lists multiple registration numbers (e.g., 1037905, 3021632375) and FEI numbers, which correspond to different models or variants of the Biliary Stone Dislodger LQR. These identifiers help track specific configurations, but the exact sizing or model selection should be confirmed with Annex Medical, Inc. for compatibility with your procedure requirements.

• What regulatory pathway was followed for the FDA clearance of the Biliary Stone Dislodger LQR, and how does this affect its use?

  The Biliary Stone Dislodger LQR received FDA clearance through a 510(k) submission (K925559) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE). This means it was determined to be as safe and effective as a legally marketed predicate device, ensuring compliance with FDA standards (regulation number 876.5010) for its intended use in biliary stone removal procedures.