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FDA 510(k)

VarioSurg 4

K-Number: K254163 · 2025-12-23

ApplicantNakanishi, Inc.
Decision Date2025-12-23
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VarioSurg 4 is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K254163. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VarioSurg 4?

VarioSurg 4 is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Nakanishi, Inc.. The 510(k) number is K254163.

When did VarioSurg 4 receive FDA 510(k) clearance?

VarioSurg 4 received FDA 510(k) clearance on 2025-12-23, under 510(k) number K254163.

Who is the listed applicant for VarioSurg 4?

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

What is the FDA product code for VarioSurg 4?

The FDA product code for VarioSurg 4 is DZI.

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Related Devices (Code: DZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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