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FDA 510(k)

THE GRAPPLR AND GRAPPLR EXTENDER

K-Number: K101616 · 2011-01-06

ApplicantTag Medical Corp.
Decision Date2011-01-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE GRAPPLR AND GRAPPLR EXTENDER is the device name listed in this FDA 510(k) record. The listed applicant is Tag Medical Corp.. It received FDA 510(k) clearance on 2011-01-06 under 510(k) number K101616. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE GRAPPLR AND GRAPPLR EXTENDER?

THE GRAPPLR AND GRAPPLR EXTENDER is a medical device that received FDA 510(k) clearance on 2011-01-06. The listed applicant is Tag Medical Corp.. The 510(k) number is K101616.

When did THE GRAPPLR AND GRAPPLR EXTENDER receive FDA 510(k) clearance?

THE GRAPPLR AND GRAPPLR EXTENDER received FDA 510(k) clearance on 2011-01-06, under 510(k) number K101616.

Who is the listed applicant for THE GRAPPLR AND GRAPPLR EXTENDER?

The FDA 510(k) record lists Tag Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE GRAPPLR AND GRAPPLR EXTENDER?

The FDA product code for THE GRAPPLR AND GRAPPLR EXTENDER is MBI.

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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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