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FDA 510(k)

Electroporation System (N3000)

K-Number: K240376 · 2024-10-04

ApplicantSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Decision Date2024-10-04
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electroporation System (N3000) 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 2024-10-04 under 510(k) number K240376. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electroporation System (N3000)?

Electroporation System (N3000) is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K240376.

When did Electroporation System (N3000) receive FDA 510(k) clearance?

Electroporation System (N3000) received FDA 510(k) clearance on 2024-10-04, under 510(k) number K240376.

Who is the listed applicant for Electroporation System (N3000)?

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 Electroporation System (N3000)?

The FDA product code for Electroporation System (N3000) is OAB.

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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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