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Integra

by Direx Systems Corp.

510(k) K053640

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 5 Oct 2026.

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053640 Date1 Mar 2006ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

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

The Integra is an Electromagnetic Extracorporeal Shock Wave Lithotripter (ESWL), classified as a urological device for the non-invasive fragmentation and expulsion of urinary stones. It employs high-energy shock waves generated electromagnetically to break down kidney, ureteral, or bladder stones into smaller particles, facilitating natural passage. The system integrates imaging capabilities to guide precise targeting of the stones while minimizing risk to surrounding tissues. This technology is designed for use in clinical settings where minimally invasive stone treatment is required.

The device is supplied as a transportable unit comprising a Shock Wave Generator (SWAG), a Fluoroscopy device (X-Ray Module), and a Patient Table. It operates as a reusable medical device, requiring appropriate sterilisation protocols between uses. The Integra is authorised under FDA 510(k) clearance (K053640) and falls under device class II, adhering to regulatory standards for extracorporeal shock wave lithotripsy systems. Storage and handling must comply with manufacturer guidelines to ensure operational integrity and patient safety.

Similar devices

Other devices filed under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological).

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