FDA 510(k)

DYONICS ELECTROBLADE RESECTOR

K-Number: K012314 · 2002-02-01

Decision Date2002-02-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DYONICS ELECTROBLADE RESECTOR 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 2002-02-01 under 510(k) number K012314. 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 RESECTOR?

DYONICS ELECTROBLADE RESECTOR is a medical device that received FDA 510(k) clearance on 2002-02-01. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K012314.

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

DYONICS ELECTROBLADE RESECTOR received FDA 510(k) clearance on 2002-02-01, under 510(k) number K012314.

Who is the listed applicant for DYONICS ELECTROBLADE RESECTOR?

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 RESECTOR?

The FDA product code for DYONICS ELECTROBLADE RESECTOR 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.