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FDA 510(k)

POREX ELECTROSURGERY NEEDLE

K-Number: K052297 · 2006-03-28

ApplicantPorex Surgical, Inc.
Decision Date2006-03-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POREX ELECTROSURGERY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Porex Surgical, Inc.. It received FDA 510(k) clearance on 2006-03-28 under 510(k) number K052297. 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 POREX ELECTROSURGERY NEEDLE?

POREX ELECTROSURGERY NEEDLE is a medical device that received FDA 510(k) clearance on 2006-03-28. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K052297.

When did POREX ELECTROSURGERY NEEDLE receive FDA 510(k) clearance?

POREX ELECTROSURGERY NEEDLE received FDA 510(k) clearance on 2006-03-28, under 510(k) number K052297.

Who is the listed applicant for POREX ELECTROSURGERY NEEDLE?

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

What is the FDA product code for POREX ELECTROSURGERY NEEDLE?

The FDA product code for POREX ELECTROSURGERY NEEDLE is GEI.

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Other records listing Porex Surgical, Inc. as applicant

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Related Devices (Code: GEI)

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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.

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