ECONOLITH EM1000— 510(k) K063504

Name: FDA 510(k) clearance K063504
Creator: U.S. Food and Drug Administration
Published: 2007-03-09

Substantially Equivalent

Medispec, Ltd.

FDA 510(k) clearance K063504 for ECONOLITH EM1000, Substantially Equivalent on 2007-03-09. Applicant: Medispec, Ltd.. Device class: 2.

Clearance details

Applicant: Medispec, Ltd.
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2006-11-20
Decision date: 2007-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germantown, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNS

view all

K261086 — Break Wave2026-04-29
K252913 — Break Wave2026-01-12
K242922 — Extracorporeal Shock Wave Lithotripter (U200)2025-06-18
K221903 — Delta III Pro2023-02-22
K213772 — LM-9300 Plus Lithotripter2023-01-19

More clearances from Medispec, Ltd.

view all

K210166 — Omnispec ED10002023-01-27
K040461 — ECONOLITH E3000, MODEL 3000 (SW-6)2004-05-25
K974796 — LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER1998-03-12

Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.