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FDA 510(k)

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories

K-Number: K192124 · 2019-11-21

Decision Date2019-11-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

When was Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories approved by the FDA?

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

What company makes Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories?

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is manufactured by Us Medical Innovations, LLC.

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.

Related Clinical Trials

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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.