MODIFICATION TO THE GRIP— 510(k) K010526

Name: FDA 510(k) clearance K010526
Creator: U.S. Food and Drug Administration
Published: 2001-12-13

Substantially Equivalent

Elcare Innovations, Inc.

FDA 510(k) clearance K010526 for MODIFICATION TO THE GRIP, Substantially Equivalent on 2001-12-13. Applicant: Elcare Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Elcare Innovations, Inc.
Product code: Code LIX
Device class: Class 2
Regulation: 21 CFR 870.5210
Advisory panel: Cardiovascular
Date received: 2001-02-22
Decision date: 2001-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burleson, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LIX

product code LIX

Other: 2
Total: 2

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.