510(k) K252662

Device: UniBur
Applicant: Nakanishi, Inc.
510(k) number: K252662
Product code: HBE
Decision: Substantially Equivalent (SESE)
Decision date: 2025-09-19
Date received: 2025-08-22
Regulation: 882.4310
Classification name: Drills, Burrs, Trephines & Accessories (Simple, Powered)
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: Y

Related Records

Applicant Contact

Contact: Kikuchi Masaaki
Address: 700 Shimohinata Kanuma JP 322-8666 322-8666

FDA Registration Numbers

3036773433
1450662
3010591625
2650143
1061124
3001592626
3004464325
3014252644
3001239363
3015453963
2183744
3003933619
3023852420
1834331
1824199
3015212339
8044015
9681479
3038472982
3025603301
3010163695
1045834
3034676720
2025102
3013557562
9610612
2246552
2027754
3015882686
3017521423
3028006458
1625507
3029300352
3017210488
3002807314
1045254
2916714
3007031059
8010177
3005382983
3003800209
3030733800
3016172274
9614948
3016438694
1287329
3009973336
3010097171
3006128100
3002808022
9680741
8043933
1649518
1058584
1030489
2953359
1526611
3015151147
3005562917
3005282635
3002807310
3010041499
1723170
3009417901
8031010
3009732568
1526534
1828288
3008812560
1835251
2133641
3003120897
1825034
2647346
2648623
3021632375
3007997036
3040335671
2134947
9611253

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HBE

510(k)	Device	Applicant	Decision date
K253627	Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)	Surgify Medical OY	2026-03-26
K250815	Hubly Drill (H100)	Hubly, Inc.	2025-11-06
K252060	GREEN	Phasor Health, LLC	2025-10-31
K251433	Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)	Surgify Medical OY	2025-06-04
K250380	Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)	Surgify Medical OY	2025-03-13
K250374	iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R	Stryker Instruments	2025-03-11
K232684	Surgify Halo	Surgify Medical OY	2023-11-29
K230619	Hubly Electric Drill (H100)	Hubly, Inc.	2023-05-04
K223199	2.1 x 255mm Drill, 22mm Stop	Biomet Microfixation	2022-11-15
K213072	2.1 x 255mm Drill, 22mm Stop	Biomet Micofixation	2022-08-23
K213208	Twist Drills	Biomet Microfixation	2021-12-23
K213454	Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm	Medtronic Powered Surgical Solutions	2021-11-23
K202120	P300 Attachment	Nakanishi, Inc.	2021-10-22
K203739	ELAN 4 Electro Motor System	Aesculap, Inc.	2021-08-24
K210377	Stryker iBur hubs and cutting accessories	Stryker Corporation	2021-06-30