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FDA 510(k)

ELECTROSURGICAL ELECTRODE

K-Number: K970987 · 1997-05-05

ApplicantFusion Medical Technologies, Inc.
Decision Date1997-05-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Medical Technologies, Inc.. It received FDA 510(k) clearance on 1997-05-05 under 510(k) number K970987. 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 ELECTROSURGICAL ELECTRODE?

ELECTROSURGICAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Fusion Medical Technologies, Inc.. The 510(k) number is K970987.

When did ELECTROSURGICAL ELECTRODE receive FDA 510(k) clearance?

ELECTROSURGICAL ELECTRODE received FDA 510(k) clearance on 1997-05-05, under 510(k) number K970987.

Who is the listed applicant for ELECTROSURGICAL ELECTRODE?

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

What is the FDA product code for ELECTROSURGICAL ELECTRODE?

The FDA product code for ELECTROSURGICAL ELECTRODE is GEI.

Related Clinical Trials

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Other records listing Fusion Medical Technologies, Inc. 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.

K964857RAPISEAL PATCHK961440SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH

Related Devices (Code: GEI)

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Official Source

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