Cleared Traditional

K802387 - MINOR DRESSING TRAY-MILFORD HOSP.

K802387 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Nov 1980
Decision
41d
Days
-
Risk

K802387 is an FDA 510(k) clearance for the MINOR DRESSING TRAY-MILFORD HOSP.. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by American Medical Disposable, Inc. (Walker, 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

FDA 510(k) Submission Details - K802387

510(k) Number K802387 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 48
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K802387.
GAUZE PADS STERILE SINGLES
K802862 · Abco Dealers, Inc. · Dec 1980
GAUZE SPONGES
K802863 · Abco Dealers, Inc. · Dec 1980
CUSTOM DRESSING TRAY/CARDINAL CUSHING
K802383 · American Medical Disposable, Inc. · Nov 1980
MAJOR DRESSING TRAY-MILFORD HOSP.
K802388 · American Medical Disposable, Inc. · Nov 1980
GUAZE BALLS CAT.#601-720
K801999 · Pollak (Intl.), Ltd. · Sep 1980
ABSORBENT PAD CAT.#729, 732, 730, 731
K802005 · Pollak (Intl.), Ltd. · Sep 1980