Cleared Traditional

K130755 - HICUT HIGHSPEED INSTRUMENT

K130755 is an FDA 510(k) clearance for HICUT HIGHSPEED INSTRUMENT, manufactured by Adeor Medical AG. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 465-day FDA review.

K130755 · Adeor Medical AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
465d
Days
Class 2
Risk

K130755 is an FDA 510(k) clearance for the HICUT HIGHSPEED INSTRUMENT. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Adeor Medical AG (Pullach, DE). The FDA issued a Cleared decision on June 27, 2014 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Adeor Medical AG devices

FDA 510(k) Submission Details - K130755

510(k) Number K130755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
317d slower than avg
Panel avg: 148d · This submission: 465d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 50
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K130755.
Stryker Footed Attachments and Cutting Accessories
K143399 · Stryker Corp. · May 2015
Stryker MIS Attachments and Cutting Accessories
K143540 · Stryker Corporation · May 2015
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K143320 · Stryker Corp. · Apr 2015
VARIOGUIDE DRILL KIT
K132436 · Mri Interventions, Inc. · Mar 2014
POWEREASE SYSTEM
K123270 · Medtronic Sofamor Danek USA, Inc. · Jan 2013
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
K121264 · Medtronic Surgical Technologies · Aug 2012