Cleared Traditional

K833266 - ACRA-CUT

K833266 is the FDA 510(k) clearance for ACRA-CUT by Acra Cut, Inc.. It is a Class 2 Neurology device (product code HBF) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K833266 · Acra Cut, Inc. · Neurology device
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Dec 1983
Decision
99d
Days
Class 2
Risk

K833266 is an FDA 510(k) clearance for the ACRA-CUT. Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Acra Cut, Inc. (Acton, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 99 days - within the typical 510(k) review window.

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 Acra Cut, Inc. devices

Submission Details

510(k) Number K833266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1983
Decision Date December 29, 1983
Days to Decision 99 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 148d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K833266.
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · The Anspach Effort, Inc. · Oct 1998
DISPOSABLE PERFORATOR
K933894 · Codman & Shurtleff, Inc. · Dec 1993
DISPOSABLE PERFORATOR
K924242 · Codman & Shurtleff, Inc. · Jul 1993
CODMAN * REUSABLE PERFORATOR
K820087 · Codman & Shurtleff, Inc. · Feb 1982
DISPOSABLE PERFORATORS, JACOBS, HUDSON
K791101 · Codman & Shurtleff, Inc. · Aug 1979