Cleared Traditional

K844673 - APPLIED GAUZE SPONGE 4X4X16 PLY (FDA 510(k) Clearance)

K844673 · Applied Medical · General & Plastic Surgery device
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Apr 1985
Decision
122d
Days
-
Risk

K844673 is an FDA 510(k) clearance for the APPLIED GAUZE SPONGE 4X4X16 PLY. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Applied Medical (Fort Worth, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 122 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 K844673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date April 01, 1985
Days to Decision 122 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
8d slower than avg
Panel avg: 114d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -