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FDA 510(k)

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories

K-Number: K192124 · 2019-11-21

ApplicantUs Medical Innovations, LLC
Decision Date2019-11-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories 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 2019-11-21 under 510(k) number K192124. 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 SMART XL-1000 Electrosurgical Generator with Accessories?

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Us Medical Innovations, LLC. The 510(k) number is K192124.

When did Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories receive FDA 510(k) clearance?

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192124.

Who is the listed applicant for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories?

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 SMART XL-1000 Electrosurgical Generator with Accessories?

The FDA product code for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is GEI.

Other records listing Us Medical Innovations, LLC as applicant

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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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