Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UniBur

K-Number: K252662 · 2025-09-19

ApplicantNakanishi, Inc.
Decision Date2025-09-19
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UniBur is a medical device manufactured by Nakanishi, Inc.. It received FDA 510(k) clearance on 2025-09-19 under approval number K252662. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniBur?

UniBur is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Nakanishi, Inc.. The 510(k) number is K252662.

When was UniBur approved by the FDA?

UniBur received FDA 510(k) clearance on 2025-09-19, under approval number K252662.

What company makes UniBur?

UniBur is manufactured by Nakanishi, Inc..

What is the FDA product code for UniBur?

The FDA product code for UniBur is HBE.

Other Devices by Nakanishi, Inc.

K171155Surgical Angle Handpiece, Surgical Straight Handpiece K163402NLZ Motor System K163483PANA SPRAY Plus K163131A-dec NLZ Electric Motor System K173905Surgic Pro, Surgic Pro+ K182999General Cutting Contra Handpiece

View all 21 devices →

Related Devices (Code: HBE)

K161704Phasor DrillBiotex, Inc. K153519DRealCarevature Medical, Ltd. K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation K162542OsteoMed PINNACLE DriverOsteomed K172709ELAN 4 Electro Motor System ToolsAesculap, Inc. K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.

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.

↑