Cleared Traditional

HICUT HIGHSPEED INSTRUMENT

K130755 · Adeor Medical AG · Neurology
Jun 2014
Decision
465d
Days
Class 2
Risk

About This 510(k) Submission

K130755 is an FDA 510(k) clearance for the HICUT HIGHSPEED INSTRUMENT, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Adeor Medical AG (Pullach, DE). The FDA issued a Cleared decision on June 27, 2014, 465 days after receiving the submission on March 19, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K130755 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2013
Decision Date June 27, 2014
Days to Decision 465 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

Similar Devices — HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 63
Hubly Drill (H100)
K250815 · Hubly, Inc. · Nov 2025
GREEN
K252060 · Phasor Health, LLC · Oct 2025
UniBur
K252662 · Nakanishi, Inc. · Sep 2025
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)
K251433 · Surgify Medical OY · Jun 2025
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)
K250380 · Surgify Medical OY · Mar 2025
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
K250374 · Stryker Instruments · Mar 2025