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FDA 510(k)

GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910

K-Number: K061417 · 2006-10-10

ApplicantGenicon
Decision Date2006-10-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 is the device name listed in this FDA 510(k) record. The listed applicant is Genicon. It received FDA 510(k) clearance on 2006-10-10 under 510(k) number K061417. 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 GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910?

GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 is a medical device that received FDA 510(k) clearance on 2006-10-10. The listed applicant is Genicon. The 510(k) number is K061417.

When did GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 receive FDA 510(k) clearance?

GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 received FDA 510(k) clearance on 2006-10-10, under 510(k) number K061417.

Who is the listed applicant for GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910?

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

What is the FDA product code for GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910?

The FDA product code for GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 is GEI.

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Other records listing Genicon 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.

K100090IMPLANTABLE CLIPK041967GENICON SUCTION IRRIGATION SYSTEMK041968GENICON BIPOLAR FORCEPS MODEL # 600-005-005

Related Devices (Code: GEI)

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Official Source

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