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FDA 510(k)

LIGASURE VESSEL SEALING SYSTEM

K-Number: K981916 · 1998-08-28

ApplicantValleylab, Inc.
Decision Date1998-08-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGASURE VESSEL SEALING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 1998-08-28 under 510(k) number K981916. 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 LIGASURE VESSEL SEALING SYSTEM?

LIGASURE VESSEL SEALING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-28. The listed applicant is Valleylab, Inc.. The 510(k) number is K981916.

When did LIGASURE VESSEL SEALING SYSTEM receive FDA 510(k) clearance?

LIGASURE VESSEL SEALING SYSTEM received FDA 510(k) clearance on 1998-08-28, under 510(k) number K981916.

Who is the listed applicant for LIGASURE VESSEL SEALING SYSTEM?

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

What is the FDA product code for LIGASURE VESSEL SEALING SYSTEM?

The FDA product code for LIGASURE VESSEL SEALING SYSTEM is GEI.

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Other records listing Valleylab, 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.

K031011LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500K010010VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATORK010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODEK983743BISURE LAPAROSCOPIC BIPOLAR FORCEPSK981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM

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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

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

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