Cleared Traditional

AWC BUTTERFLY WOUND CLOSURES (K894802) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K894802 · American White Cross, Inc. · General & Plastic Surgery device
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Jan 1990
Decision
187d
Days
Class 1
Risk

K894802 is an FDA 510(k) clearance for the AWC BUTTERFLY WOUND CLOSURES. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by American White Cross, Inc. (New Rochelle, US). The FDA issued a Cleared decision on January 31, 1990 after a review of 187 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device framework. 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 American White Cross, Inc. devices

Submission Details

510(k) Number K894802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1989
Decision Date January 31, 1990
Days to Decision 187 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
72d slower than avg
Panel avg: 115d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPX Strip, Adhesive, Closure, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FPX Strip, Adhesive, Closure, Skin

All 9
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K894802.
DERMA STRIP-TM SKIN CLOSURES
K833083 · Howmedica Corp. · Dec 1983
BAND AID* ADHESIVE BANDAGES
K782003 · Johnson & Johnson Professionals, Inc. · Jan 1979
PAPER TAPE, HYPO ALLERGENIC
K781952 · Johnson & Johnson Professionals, Inc. · Dec 1978
SUTURELESS SKIN CLOSURE
K780565 · Abbott Laboratories · Jul 1978
CLOTH ADHESIVE TAPE
K772020 · Johnson & Johnson Professionals, Inc. · Nov 1977
BAND-AID BRAND ADHES. BAND.-SHEER STRIPS
K770533 · Johnson & Johnson Professionals, Inc. · Jun 1977