FDA 510(k)

Surn5 Electrosurgical Argon Beam Generator and Accessories

K-Number: K203522 · 2021-02-22

Decision Date2021-02-22

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Surn5 Electrosurgical Argon Beam Generator and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Surnic Corporation. It received FDA 510(k) clearance on 2021-02-22 under 510(k) number K203522. 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 Surn5 Electrosurgical Argon Beam Generator and Accessories?

Surn5 Electrosurgical Argon Beam Generator and Accessories is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Surnic Corporation. The 510(k) number is K203522.

When did Surn5 Electrosurgical Argon Beam Generator and Accessories receive FDA 510(k) clearance?

Surn5 Electrosurgical Argon Beam Generator and Accessories received FDA 510(k) clearance on 2021-02-22, under 510(k) number K203522.

Who is the listed applicant for Surn5 Electrosurgical Argon Beam Generator and Accessories?

The FDA 510(k) record lists Surnic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surn5 Electrosurgical Argon Beam Generator and Accessories?

The FDA product code for Surn5 Electrosurgical Argon Beam Generator and Accessories is GEI.

Other records listing Surnic Corporation as applicant

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Official Source

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