Varios Combi Pro2
K-Number: K260773 · 2026-03-10
ApplicantNakanishi, Inc.
Decision Date2026-03-10
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Varios Combi Pro2 is a medical device manufactured by Nakanishi, Inc.. It received FDA 510(k) clearance on 2026-03-10 under approval 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. It is manufactured by Nakanishi, Inc.. The 510(k) number is K260773.
When was Varios Combi Pro2 approved by the FDA?
Varios Combi Pro2 received FDA 510(k) clearance on 2026-03-10, under approval number K260773.
What company makes Varios Combi Pro2?
Varios Combi Pro2 is manufactured by Nakanishi, Inc..
What is the FDA product code for Varios Combi Pro2?
The FDA product code for Varios Combi Pro2 is ELC.
Other Devices by Nakanishi, Inc.
Related Devices (Code: ELC)
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.