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FDA 510(k)

Varios Combi Pro2

K-Number: K260773 · 2026-03-10

Decision Date2026-03-10
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Varios Combi Pro2 is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2026-03-10 under 510(k) number K260773. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Varios Combi Pro2?

Varios Combi Pro2 is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Nakanishi, Inc.. The 510(k) number is K260773.

When did Varios Combi Pro2 receive FDA 510(k) clearance?

Varios Combi Pro2 received FDA 510(k) clearance on 2026-03-10, under 510(k) number K260773.

Who is the listed applicant for Varios Combi Pro2?

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 Varios Combi Pro2?

The FDA product code for Varios Combi Pro2 is ELC.

Other records listing Nakanishi, Inc. as applicant

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.

View all 21 devices →

Related Devices (Code: ELC)

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.

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.