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Vibrolith and Vibrolith Plus Intracorporeal Lithotriptor

by Elmed USA

510(k) K092033

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092033 Date30 Apr 2010ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FFK
Device Class
Class II
Regulation
21 CFR Part 876.4480
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vibrolith and Vibrolith Plus are intracorporeal lithotriptors designed for the fragmentation of urinary tract stones. These devices utilize pneumatic or combined pneumatic and ultrasonic energy to break down calculi within the kidney, ureter, and bladder.

This device is classified as a Class 2 electro-hydraulic lithotriptor under regulation number 876.4480. It has received FDA 510(k) clearance for use in gastroenterology and urology clinical settings.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Vibrolith and Vibrolith Plus?

    These devices are intracorporeal lithotriptors designed specifically for the fragmentation of calculi within the urinary tract, including stones located in the kidney, ureter, and bladder.

  • What energy sources do these lithotriptors use to break down stones?

    The Vibrolith and Vibrolith Plus utilize pneumatic energy or a combination of pneumatic and ultrasonic energy to effectively fragment urinary tract stones during clinical procedures.

  • What is the regulatory status of these devices?

    The Vibrolith and Vibrolith Plus have received FDA 510(k) clearance. They are classified as Class 2 electro-hydraulic lithotriptors under regulation number 876.4480 for use in urology and gastroenterology settings.