Cleared Special

ECONOLITH E3000, MODEL 3000 (SW-6)

K040461 · Medispec, Ltd. · Gastroenterology & Urology

May 2004

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K040461 is an FDA 510(k) clearance for the ECONOLITH E3000, MODEL 3000 (SW-6), a Lithotriptor, Extracorporeal Shock-wave, Urological (Class II — Special Controls, product code LNS), submitted by Medispec, Ltd. (Germantown, US). The FDA issued a Cleared decision on May 25, 2004, 92 days after receiving the submission on February 23, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5990.

Submission Details

510(k) Number	K040461 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2004
Decision Date	May 25, 2004
Days to Decision	92 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF