FDA 510(k)

Ultrasonic Surgical & Electrosurgical Generator

K-Nummer: K210488 · 2021-10-25

AntragstellerSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Entscheidungsdatum2021-10-25

ProduktcodeGEI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Ultrasonic Surgical & Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2021-10-25 under 510(k) number K210488. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Ultrasonic Surgical & Electrosurgical Generator?

Ultrasonic Surgical & Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K210488.

When did Ultrasonic Surgical & Electrosurgical Generator receive FDA 510(k) clearance?

Ultrasonic Surgical & Electrosurgical Generator received FDA 510(k) clearance on 2021-10-25, under 510(k) number K210488.

Who is the listed applicant for Ultrasonic Surgical & Electrosurgical Generator?

The FDA 510(k) record lists Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasonic Surgical & Electrosurgical Generator?

The FDA product code for Ultrasonic Surgical & Electrosurgical Generator is GEI.

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Offizielle Quelle

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