FDA 510(k)

LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS

K-Number: K043273 · 2005-01-05

Decision Date2005-01-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab. It received FDA 510(k) clearance on 2005-01-05 under 510(k) number K043273. 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 INSTRUMENTS?

LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2005-01-05. The listed applicant is Valleylab. The 510(k) number is K043273.

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

LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS received FDA 510(k) clearance on 2005-01-05, under 510(k) number K043273.

Who is the listed applicant for LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS?

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

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

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

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Other records listing Valleylab as applicant

K092879LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER K063195LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 K053535VIVAWAVE MICROWAVE ABLATION SYSTEM K053290COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES K052796COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES K051644VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR

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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.