Cleared Traditional

ANSPACH COUPLER

K050628 · The Anspach Effort, Inc. · Neurology
Apr 2005
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K050628 is an FDA 510(k) clearance for the ANSPACH COUPLER, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on April 7, 2005, 27 days after receiving the submission on March 11, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K050628 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2005
Decision Date April 07, 2005
Days to Decision 27 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