FDA 510(k)

HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE

K-Number: K844372 · 1985-02-21

ApplicantConsolidated Medical Equipment, Inc.

Decision Date1985-02-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Medical Equipment, Inc.. It received FDA 510(k) clearance on 1985-02-21 under 510(k) number K844372. 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 HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE?

HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE is a medical device that received FDA 510(k) clearance on 1985-02-21. The listed applicant is Consolidated Medical Equipment, Inc.. The 510(k) number is K844372.

When did HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE receive FDA 510(k) clearance?

HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE received FDA 510(k) clearance on 1985-02-21, under 510(k) number K844372.

Who is the listed applicant for HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE?

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

What is the FDA product code for HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE?

The FDA product code for HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE 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.