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FDA 510(k)

TISSUELINK BIPOLAR FLOATING BALL DEVICE

K-Number: K022532 · 2003-02-12

ApplicantTissuelink Medical, Inc.
Decision Date2003-02-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TISSUELINK BIPOLAR FLOATING BALL DEVICE 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 2003-02-12 under 510(k) number K022532. 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 BIPOLAR FLOATING BALL DEVICE?

TISSUELINK BIPOLAR FLOATING BALL DEVICE is a medical device that received FDA 510(k) clearance on 2003-02-12. The listed applicant is Tissuelink Medical, Inc.. The 510(k) number is K022532.

When did TISSUELINK BIPOLAR FLOATING BALL DEVICE receive FDA 510(k) clearance?

TISSUELINK BIPOLAR FLOATING BALL DEVICE received FDA 510(k) clearance on 2003-02-12, under 510(k) number K022532.

Who is the listed applicant for TISSUELINK BIPOLAR FLOATING BALL DEVICE?

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 BIPOLAR FLOATING BALL DEVICE?

The FDA product code for TISSUELINK BIPOLAR FLOATING BALL DEVICE 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 21-202-1K020574TISSUELINK BIPOLAR FLOATING BALL DEVICE

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Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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