Cleared Traditional

ENDOMED 433 (K823362) - FDA 510(k) Clearance

K823362 · Kipp & Zonen · Physical Medicine device
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Mar 1983
Decision
120d
Days
-
Risk

K823362 is an FDA 510(k) clearance for the ENDOMED 433.

Submitted by Kipp & Zonen (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Physical Medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K823362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1982
Decision Date March 09, 1983
Days to Decision 120 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -