Cleared Traditional

K905136 - GAUZE SPONGES, INTERNAL AND EXTERNAL (FDA 510(k) Clearance)

K905136 · American Healthcare Corp. · General & Plastic Surgery device
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Mar 1991
Decision
111d
Days
-
Risk

K905136 is an FDA 510(k) clearance for the GAUZE SPONGES, INTERNAL AND EXTERNAL. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by American Healthcare Corp. (Canada, CA). The FDA issued a Cleared decision on March 6, 1991 after a review of 111 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 K905136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date March 06, 1991
Days to Decision 111 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
3d faster than avg
Panel avg: 114d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -