FDA 510(k)

CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES

K-Number: K100669 · 2011-04-06

Decision Date2011-04-06

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2011-04-06 under 510(k) number K100669. 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 CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES?

CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES is a medical device that received FDA 510(k) clearance on 2011-04-06. The listed applicant is Us Medical Innovations, LLC. The 510(k) number is K100669.

When did CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES receive FDA 510(k) clearance?

CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES received FDA 510(k) clearance on 2011-04-06, under 510(k) number K100669.

Who is the listed applicant for CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES?

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

What is the FDA product code for CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES?

The FDA product code for CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES 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.