FDA 510(k)

LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500

K-Number: K031011 · 2003-05-29

Decision Date2003-05-29

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab, Inc.. It received FDA 510(k) clearance on 2003-05-29 under 510(k) number K031011. 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 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500?

LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 is a medical device that received FDA 510(k) clearance on 2003-05-29. The listed applicant is Valleylab, Inc.. The 510(k) number is K031011.

When did LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 receive FDA 510(k) clearance?

LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 received FDA 510(k) clearance on 2003-05-29, under 510(k) number K031011.

Who is the listed applicant for LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500?

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 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500?

The FDA product code for LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 is GEI.

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Other records listing Valleylab, Inc. as applicant

K010010VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR K010013LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 K994428E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE K983743BISURE LAPAROSCOPIC BIPOLAR FORCEPS K981916LIGASURE VESSEL SEALING SYSTEM K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM

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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.