FDA 510(k)

TIGERPAW SYSTEM II

K-Number: K111064 · 2011-05-18

Decision Date2011-05-18

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TIGERPAW SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Laax, Inc.. It received FDA 510(k) clearance on 2011-05-18 under 510(k) number K111064. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIGERPAW SYSTEM II?

TIGERPAW SYSTEM II is a medical device that received FDA 510(k) clearance on 2011-05-18. The listed applicant is Laax, Inc.. The 510(k) number is K111064.

When did TIGERPAW SYSTEM II receive FDA 510(k) clearance?

TIGERPAW SYSTEM II received FDA 510(k) clearance on 2011-05-18, under 510(k) number K111064.

Who is the listed applicant for TIGERPAW SYSTEM II?

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

What is the FDA product code for TIGERPAW SYSTEM II?

The FDA product code for TIGERPAW SYSTEM II is GDW.

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Other records listing Laax, Inc. as applicant

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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.