Cleared Traditional

K832795 - HEIFETZ INTRACRANIAL ANEURYSM CLIPS (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832795 · Edward Weck, Inc. · Neurology device
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Nov 1983
Decision
99d
Days
Class 2
Risk

K832795 is an FDA 510(k) clearance for the HEIFETZ INTRACRANIAL ANEURYSM CLIPS. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 25, 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 882.5200 - 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 Edward Weck, Inc. devices

Submission Details

510(k) Number K832795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date November 25, 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 HCH Clip, Aneurysm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5200
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.