FDA 510(k)

DYONICS ELECTROBLADE

K-Number: K994365 · 2000-03-13

Decision Date2000-03-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DYONICS ELECTROBLADE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K994365. 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 DYONICS ELECTROBLADE?

DYONICS ELECTROBLADE is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K994365.

When did DYONICS ELECTROBLADE receive FDA 510(k) clearance?

DYONICS ELECTROBLADE received FDA 510(k) clearance on 2000-03-13, under 510(k) number K994365.

Who is the listed applicant for DYONICS ELECTROBLADE?

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

What is the FDA product code for DYONICS ELECTROBLADE?

The FDA product code for DYONICS ELECTROBLADE 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.