FDA 510(k)

MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15

K-Number: K981416 · 1998-06-24

ApplicantMagna Advanced Technologies, Inc.

Decision Date1998-06-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 is the device name listed in this FDA 510(k) record. The listed applicant is Magna Advanced Technologies, Inc.. It received FDA 510(k) clearance on 1998-06-24 under 510(k) number K981416. 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 MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15?

MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 is a medical device that received FDA 510(k) clearance on 1998-06-24. The listed applicant is Magna Advanced Technologies, Inc.. The 510(k) number is K981416.

When did MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 receive FDA 510(k) clearance?

MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 received FDA 510(k) clearance on 1998-06-24, under 510(k) number K981416.

Who is the listed applicant for MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15?

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

What is the FDA product code for MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15?

The FDA product code for MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 is GEI.

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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.