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FDA 510(k)

LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER

K-Number: K092879 · 2009-10-16

ApplicantValleylab
Decision Date2009-10-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER is the device name listed in this FDA 510(k) record. The listed applicant is Valleylab. It received FDA 510(k) clearance on 2009-10-16 under 510(k) number K092879. 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 BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER?

LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER is a medical device that received FDA 510(k) clearance on 2009-10-16. The listed applicant is Valleylab. The 510(k) number is K092879.

When did LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER receive FDA 510(k) clearance?

LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER received FDA 510(k) clearance on 2009-10-16, under 510(k) number K092879.

Who is the listed applicant for LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER?

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 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER?

The FDA product code for LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER is GEI.

Related Clinical Trials

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.

Other records listing Valleylab 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.

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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.

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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