ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM— 510(k) K020082

Name: FDA 510(k) clearance K020082
Creator: U.S. Food and Drug Administration
Published: 2002-02-05

Substantially Equivalent

Endocare, Inc.

FDA 510(k) clearance K020082 for ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM, Substantially Equivalent on 2002-02-05. Applicant: Endocare, Inc.. Device class: 2.

Clearance details

Applicant: Endocare, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 2002-01-10
Decision date: 2002-02-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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