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FDA 510(k)

MODIFICATION TO THE GRIP

K-Number: K010526 · 2001-12-13

ApplicantElcare Innovations, Inc.
Decision Date2001-12-13
Product CodeLIX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THE GRIP is the device name listed in this FDA 510(k) record. The listed applicant is Elcare Innovations, Inc.. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K010526. The device is classified under product code LIX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO THE GRIP?

MODIFICATION TO THE GRIP is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is Elcare Innovations, Inc.. The 510(k) number is K010526.

When did MODIFICATION TO THE GRIP receive FDA 510(k) clearance?

MODIFICATION TO THE GRIP received FDA 510(k) clearance on 2001-12-13, under 510(k) number K010526.

Who is the listed applicant for MODIFICATION TO THE GRIP?

The FDA 510(k) record lists Elcare Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO THE GRIP?

The FDA product code for MODIFICATION TO THE GRIP is LIX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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