Candela Stone Baskets

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

510(k) Number

K884738 ↗

FDA Product Code

FFL

Device Class

Class II

Regulation

21 CFR Part 876.4680

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Candela Directable Biliary Catheter System

  Class II

  FDA 510(k) K900904 Active Cleared 11 May 1990

• Candela Cryo-Probe Holder

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  FDA 510(k) K954872 Active Cleared 5 Feb 1996

• Candela Sptl Pulsed Dye Lasers

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  FDA 510(k) K931762 Active Cleared 15 Mar 1994

• Candela Q-Switched Alexandrite Laser

  Class II

  FDA 510(k) K940173 Active Cleared 7 Dec 1994

• Sptl-1 Pulsed Dye Laser

  Class II

  FDA 510(k) K882243 Active Cleared 5 Jul 1988

See all devices from Candela Laser Corp. →

• What clinical specialties are the Candela Stone Baskets primarily intended for use in, and why?

  The Candela Stone Baskets are primarily intended for use in urology and gastroenterology procedures. This is supported by their FDA 510(k) clearance under the Gastroenterology and Urology advisory committees, as well as their classification under product code FFL (Flexible Endoscopic Devices) and OpenFDA medical specialty designation, which aligns with endoscopic retrieval techniques in these specialties.

• Are the Candela Stone Baskets reusable, or are they designed for single-use only? How does this affect their clinical workflow?

  The Candela Stone Baskets are intended for single-use only, as explicitly stated in their description. This design ensures sterility and reduces the risk of cross-contamination between patients, simplifying clinical workflows by eliminating the need for reprocessing or sterilization between cases.

• How do I determine which size or model of Candela Stone Basket is appropriate for my patient’s procedure?

  The Candela Stone Baskets come in multiple sizes and models, each denoted by unique registration numbers (e.g., 3011193403, 1000117748). These variations are designed to accommodate different procedural needs, such as varying ureteral stone sizes or anatomical considerations. Consulting the manufacturer’s documentation or a urologist’s guidance will help select the appropriate size for optimal retrieval during endoscopic procedures.

• How should the Candela Stone Baskets be stored to maintain their integrity and sterility?

  Since the Candela Stone Baskets are supplied sterile, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility and prevents damage to the basket mechanism, which is critical for effective stone retrieval during procedures.

• What regulatory pathway was followed for the FDA clearance of the Candela Stone Baskets, and what does this mean for clinicians?

  The Candela Stone Baskets received FDA 510(k) clearance (K884738) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined the device is as safe and effective as a previously cleared ureteral stone dislodger, ensuring clinicians can rely on its established performance and safety standards for ureteral stone retrieval in endoscopic procedures.