Cleared Traditional

OPERATING ROOM PROCEDURAL PACK (K822804) - FDA 510(k) Clearance

K822804 · Adicon · General & Plastic Surgery device
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Dec 1982
Decision
102d
Days
-
Risk

K822804 is an FDA 510(k) clearance for the OPERATING ROOM PROCEDURAL PACK.

Submitted by Adicon (Walker, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 102 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 K822804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1982
Decision Date December 28, 1982
Days to Decision 102 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: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -