FDA 510(k)

DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL

K-Number: K961647 · 1996-10-08

Decision Date1996-10-08

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1996-10-08 under 510(k) number K961647. 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 DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL?

DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K961647.

When did DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL receive FDA 510(k) clearance?

DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL received FDA 510(k) clearance on 1996-10-08, under 510(k) number K961647.

Who is the listed applicant for DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL?

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

What is the FDA product code for DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL?

The FDA product code for DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL 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.