Cleared Traditional

K823424 - MENISCECTOMY TRAY #9715

K823424 is an FDA 510(k) clearance for MENISCECTOMY TRAY #9715, manufactured by Concept, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K823424 · Concept, Inc. · Neurology device
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Mar 1983
Decision
121d
Days
Class 2
Risk

K823424 is an FDA 510(k) clearance for the MENISCECTOMY TRAY #9715. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Concept, Inc. (Walker, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Concept, Inc. devices

FDA 510(k) Submission Details - K823424

510(k) Number K823424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1982
Decision Date March 17, 1983
Days to Decision 121 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 148d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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.