Cleared Traditional

K842967 - AQUAPHOR R GAUZE

K842967 · Beiersdorf, Inc. · General & Plastic Surgery device
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Nov 1984
Decision
104d
Days
-
Risk

K842967 is an FDA 510(k) clearance for the AQUAPHOR R GAUZE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on November 8, 1984 after a review of 104 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.

View all Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K842967

510(k) Number K842967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1984
Decision Date November 08, 1984
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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COMFEEL ULCUS SHEET
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