FDA 510(k)

TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT

K-Number: K073495 · 2008-01-09

Decision Date2008-01-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Tissuelink Medical, Inc.. It received FDA 510(k) clearance on 2008-01-09 under 510(k) number K073495. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT?

TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT is a medical device that received FDA 510(k) clearance on 2008-01-09. The listed applicant is Tissuelink Medical, Inc.. The 510(k) number is K073495.

When did TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT receive FDA 510(k) clearance?

TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT received FDA 510(k) clearance on 2008-01-09, under 510(k) number K073495.

Who is the listed applicant for TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT?

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

What is the FDA product code for TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT?

The FDA product code for TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT is GEI.

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Other records listing Tissuelink Medical, Inc. as applicant

K063639AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 K052859AQUAMANTYS PUMP GENERATOR SYSTEM K032132TISSUELINK FLOATING BALL MODEL 23-201-1 K030380TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1 K022532TISSUELINK BIPOLAR FLOATING BALL DEVICE K020574TISSUELINK BIPOLAR FLOATING BALL DEVICE

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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.