Cleared Traditional

MAJOR DRESSING TRAY-MILFORD HOSP. (K802388) - FDA 510(k) Clearance

K802388 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Nov 1980
Decision
41d
Days
-
Risk

K802388 is an FDA 510(k) clearance for the MAJOR DRESSING TRAY-MILFORD HOSP.. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 41 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Medical Disposable, Inc. devices

Submission Details

510(k) Number K802388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1980
Decision Date November 12, 1980
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -