Cleared Traditional

K231403 - evoDrill Cranial Perforator

K231403 is an FDA 510(k) clearance for evoDrill Cranial Perforator, manufactured by Evonos GmbH & Co. KG. The device is a Class 2 Neurology device with product code HBF cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K231403 · Evonos GmbH & Co. KG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
296d
Days
Class 2
Risk

K231403 is an FDA 510(k) clearance for the evoDrill Cranial Perforator. Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Evonos GmbH & Co. KG (Tuttingen, DE). The FDA issued a Cleared decision on March 6, 2024 after a review of 296 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4305 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Evonos GmbH & Co. KG devices

FDA 510(k) Submission Details - K231403

510(k) Number K231403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2023
Decision Date March 06, 2024
Days to Decision 296 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 148d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBF Device Classification - Class 2, Special Controls

Product Code HBF Drills, Burrs, Trephines & Accessories (compound, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4305
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 - HBF Drills, Burrs, Trephines & Accessories (compound, Powered)

All 10
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K231403.
NeuroLine Disposable Cranial Perforator with Hudson end
K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. · Jun 2022
Codman Disposable Perforators
K183581 · Integra Lifesciences Corp. · Jan 2019
CRANIAL PERFORATOR
K082637 · The Anspach Effort, Inc. · Dec 2008
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
K073336 · Codman & Shurtleff, Inc. · Jan 2008
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
K071931 · Codman & Shurtleff, Inc. · Oct 2007
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · The Anspach Effort, Inc. · Oct 1998