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FDA 510(k)

SMOKEVAC ELECTORSURGICAL PENCIL

K-Number: K881460 · 1988-05-04

ApplicantByron Medical
Decision Date1988-05-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMOKEVAC ELECTORSURGICAL PENCIL is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1988-05-04 under 510(k) number K881460. 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 SMOKEVAC ELECTORSURGICAL PENCIL?

SMOKEVAC ELECTORSURGICAL PENCIL is a medical device that received FDA 510(k) clearance on 1988-05-04. The listed applicant is Byron Medical. The 510(k) number is K881460.

When did SMOKEVAC ELECTORSURGICAL PENCIL receive FDA 510(k) clearance?

SMOKEVAC ELECTORSURGICAL PENCIL received FDA 510(k) clearance on 1988-05-04, under 510(k) number K881460.

Who is the listed applicant for SMOKEVAC ELECTORSURGICAL PENCIL?

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

What is the FDA product code for SMOKEVAC ELECTORSURGICAL PENCIL?

The FDA product code for SMOKEVAC ELECTORSURGICAL PENCIL is GEI.

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Other records listing Byron Medical as applicant

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Related Devices (Code: GEI)

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.

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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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