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FDA 510(k)

AQUAMANTYS PUMP GENERATOR SYSTEM

K-Number: K052859 · 2005-10-25

ApplicantTissuelink Medical, Inc.
Decision Date2005-10-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUAMANTYS PUMP GENERATOR SYSTEM 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 2005-10-25 under 510(k) number K052859. 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 PUMP GENERATOR SYSTEM?

AQUAMANTYS PUMP GENERATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-25. The listed applicant is Tissuelink Medical, Inc.. The 510(k) number is K052859.

When did AQUAMANTYS PUMP GENERATOR SYSTEM receive FDA 510(k) clearance?

AQUAMANTYS PUMP GENERATOR SYSTEM received FDA 510(k) clearance on 2005-10-25, under 510(k) number K052859.

Who is the listed applicant for AQUAMANTYS PUMP GENERATOR SYSTEM?

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 PUMP GENERATOR SYSTEM?

The FDA product code for AQUAMANTYS PUMP GENERATOR SYSTEM 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.

K073495TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHTK063639AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1K032132TISSUELINK FLOATING BALL MODEL 23-201-1K030380TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1K022532TISSUELINK BIPOLAR FLOATING BALL DEVICEK020574TISSUELINK BIPOLAR FLOATING BALL DEVICE

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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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