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Stonelith Model V5

by Pck Electronic Industry and Trade Co, Ltd.

510(k) K011106

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 NumberK011106 Date11 Feb 2002ClearedStatusActive

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  • Withdrawn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
LNS
Device Class
Class II
Regulation
21 CFR Part 876.5990
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 device is a Lithotriptor, Extracorporeal Shock-Wave, Urological, as defined in the FDA 510(k) clearance documentation. It is substantially equivalent to a predicate device and classified under product code LNS.

It received FDA 510(k) clearance K011106 on February 11, 2002, following submission on April 11, 2001. The device is manufactured by Pck Electronic Industry and Trade Co, Ltd. in Ankara, Turkey, and is indicated for use in gastroenterology and urology specialties.

Other devices from Pck Electronic Industry and Trade Co, Ltd.

Questions

AI-generated answers, 25 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 STONELITH MODEL V5 used for?

    The STONELITH MODEL V5 is indicated for use in gastroenterology and urology specialties as an extracorporeal shock-wave lithotriptor, designed to fragment urinary or biliary stones non-invasively using focused shock waves.

  • How was the STONELITH MODEL V5 authorized for market release?

    The device received FDA 510(k) clearance K011106 on February 11, 2002, after being found substantially equivalent to a predicate device, based on its technical specifications and intended use in lithotripsy procedures.

  • Who manufactures the STONELITH MODEL V5 and where is it produced?

    The STONELITH MODEL V5 is manufactured by Pck Electronic Industry and Trade Co, Ltd., located at 59/1 Sancak, Cankaya, Ankara, Turkey, with postal code 06550 and country code TR.