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FDA 510(k)

AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1

K-Number: K063639 · 2007-02-22

ApplicantTissuelink Medical, Inc.
Decision Date2007-02-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 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 2007-02-22 under 510(k) number K063639. 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 AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1?

AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 is a medical device that received FDA 510(k) clearance on 2007-02-22. The listed applicant is Tissuelink Medical, Inc.. The 510(k) number is K063639.

When did AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 receive FDA 510(k) clearance?

AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 received FDA 510(k) clearance on 2007-02-22, under 510(k) number K063639.

Who is the listed applicant for AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1?

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 AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1?

The FDA product code for AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 is GEI.

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Other records listing Tissuelink Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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