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FDA 510(k)

MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL

K-Number: K010662 · 2001-04-27

ApplicantTissuelink Medical, Inc.
Decision Date2001-04-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL 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 2001-04-27 under 510(k) number K010662. 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 MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL?

MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Tissuelink Medical, Inc.. The 510(k) number is K010662.

When did MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL receive FDA 510(k) clearance?

MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010662.

Who is the listed applicant for MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL?

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 MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL?

The FDA product code for MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL 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 23-121-1K052859AQUAMANTYS PUMP GENERATOR SYSTEMK032132TISSUELINK FLOATING BALL MODEL 23-201-1K030380TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1K022532TISSUELINK BIPOLAR FLOATING BALL DEVICE

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Related Devices (Code: GEI)

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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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