Cleared Traditional

K891097 - DAMOR CREAM SATURATED DRESSING

K891097 · Damor America, Inc. · General & Plastic Surgery device
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Aug 1989
Decision
176d
Days
-
Risk

K891097 is an FDA 510(k) clearance for the DAMOR CREAM SATURATED DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Damor America, Inc. (Vienna, US). The FDA issued a Cleared decision on August 25, 1989 after a review of 176 days - an extended review 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: 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 Damor America, Inc. devices

FDA 510(k) Submission Details - K891097

510(k) Number K891097 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 02, 1989
Decision Date August 25, 1989
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 527
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K891097.
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990
KALTOCARB WOUND DRESSING
K894347 · Calgon Vestal Div. · Aug 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · Smith & Nephew United, Inc. · Aug 1989
KALTOSTAT WOUND PACKING
K892868 · Calgon Vestal Div. · Jul 1989