Cleared Traditional

K832816 - HALL ARTHROTOME (FDA 510(k) Clearance)

K832816 · American Sterilizer Co. · General & Plastic Surgery device
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Nov 1983
Decision
101d
Days
-
Risk

K832816 is an FDA 510(k) clearance for the HALL ARTHROTOME.

Submitted by American Sterilizer Co. (Walker, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K832816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date November 28, 1983
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 114d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -