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EL27-Compact Sterile EHL-Probes

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K230488

by Walz Elektronik Gmbh

Identifiers

510(k) Number
K230488 FDA 510(k)
FDA Product Code
FFK FDA 510(k)
Models / Variants
EL27-Compact FDA 510(k)EUDAMED
Sterile EHL-Probes FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4480 FDA 510(k)
Regulation Number
876.4480 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EL27-Compact Sterile EHL-Probes are classified as electro-hydraulic lithotriptors, designed for the fragmentation of urinary or biliary calculi through high-energy shockwaves generated by electro-hydraulic discharge. These probes are intended for use in urological and gastroenterological procedures to break down stones within the urinary tract or bile ducts, facilitating their subsequent removal.

Supplied sterile and intended for single-use, these probes are regulated under the FDA’s 510(k) pathway with a determination of substantial equivalence (SESE) and comply with EU MDR requirements. They are manufactured by Walz Elektronik GmbH and are classified as Class II devices, with specific regulatory registration numbers listed in the OpenFDA database. Storage and handling must adhere to sterile field protocols to maintain integrity prior to use.

Frequently asked questions

What medical specialties are these probes primarily intended for, and how does that relate to their use?

The EL27-Compact Sterile EHL-Probes are designed for use in urological and gastroenterological procedures, as indicated by their classification under the Gastroenterology and Urology advisory committees (GU). This means they are specifically engineered to break down urinary or biliary calculi (stones) in the urinary tract or bile ducts, facilitating their removal. Clinicians in these specialties rely on these probes to deliver high-energy shockwaves via electro-hydraulic discharge, making them suitable for stone fragmentation in relevant anatomical areas.

Are these probes reusable, or are they meant for single-use only? What does that mean for sterile handling?

The EL27-Compact Sterile EHL-Probes are intended for single-use only, as explicitly stated in the product description. This means each probe is pre-sterilized and should remain unopened until use, adhering to sterile field protocols to preserve integrity. After use, they must be discarded to prevent contamination or reuse, ensuring patient safety and compliance with sterile medical device handling standards.

What regulatory pathways have these probes gone through, and how does that affect their use in the U.S.?

The EL27-Compact Sterile EHL-Probes were cleared via the FDA’s 510(k) pathway, with a determination of substantial equivalence (SESE). This means they were compared to a predicate device and found to have the same intended use and technological characteristics, ensuring they meet FDA safety and effectiveness standards. Clinicians can rely on this clearance when integrating the probes into urological or gastroenterological procedures, as it confirms regulatory validation for their intended purpose.

How are these probes stored, and what precautions should be taken before use?

Since the EL27-Compact Sterile EHL-Probes are supplied sterile, they must be stored in their original packaging until ready for use to maintain sterility. The packaging should remain intact and protected from contamination, moisture, or physical damage. Before use, clinicians should verify the probe’s sterility by checking for any tears, leaks, or expiration dates on the packaging, ensuring compliance with sterile field protocols to prevent infection risks during procedures.

What types of stones can these probes effectively fragment, and in which anatomical locations?

The EL27-Compact Sterile EHL-Probes are designed to fragment urinary or biliary calculi (stones) within the urinary tract or bile ducts. Their electro-hydraulic discharge technology generates high-energy shockwaves to break down stones in these specific anatomical areas, making them suitable for procedures where stone removal is required. Clinicians in urology and gastroenterology use them to facilitate the disintegration of obstructions in these critical pathways.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Walz Elektronik Gmbh

Sources (2)

  • FDA 510(k) K230488 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026