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 a medical device manufactured by Nakanishi, Inc.. It received FDA 510(k) clearance on 2025-12-23 under approval 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. It is manufactured by Nakanishi, Inc.. The 510(k) number is K254163.
When was VarioSurg 4 approved by the FDA?
VarioSurg 4 received FDA 510(k) clearance on 2025-12-23, under approval number K254163.
What company makes VarioSurg 4?
VarioSurg 4 is manufactured by Nakanishi, Inc..
What is the FDA product code for VarioSurg 4?
The FDA product code for VarioSurg 4 is DZI.
Other Devices by Nakanishi, Inc.
Related Devices (Code: DZI)
K152125Oral Surgery System and AccessoriesBonart Co., Ltd.
K172137PIEZOTOME CUBESatelec - Acteon Group
K171326Piezosurgery WhiteMectron S.P.A.
K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITEMectron S.P.A.
K192561TRAUS SUS20Saeshin Precision Co., Ltd.
K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC
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.