Cleared Traditional

K894541 - CARRINGTON DERMAL WOUND GEL

K894541 · Carrington Laboratories, Inc. · General & Plastic Surgery device
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Nov 1989
Decision
133d
Days
-
Risk

K894541 is an FDA 510(k) clearance for the CARRINGTON DERMAL WOUND GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Carrington Laboratories, Inc. (Dallas, US). The FDA issued a Cleared decision on November 30, 1989 after a review of 133 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 Carrington Laboratories, Inc. devices

FDA 510(k) Submission Details - K894541

510(k) Number K894541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date November 30, 1989
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 280
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K894541.
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