Cleared Traditional

K830593 - ENSURE DRESSING

K830593 is an FDA 510(k) clearance for ENSURE DRESSING, manufactured by Warner-Lambert Co.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K830593 · Warner-Lambert Co. · General & Plastic Surgery device
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Apr 1983
Decision
41d
Days
Class 1
Risk

K830593 is an FDA 510(k) clearance for the ENSURE DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K830593

510(k) Number K830593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1983
Decision Date April 06, 1983
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.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 107
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K830593.
TRIANGLE BANDAGE STERILE
K831283 · Pac-Kit Safety Equipment Co. · Aug 1983
UNI-THANE
K831611 · Carapac Systems, Inc. · Jun 1983
MOLNLYCKE MEPORE STERILE SELF-ADHESIVE
K830050 · Lada Intl., Inc. · Jun 1983
CHESEBROUGH-POND'S MULTILAYER ELASTIC
K823852 · Chesebrough-Pond'S U.S.A. Co. · Mar 1983
BURN DRESSING
K830089 · Action Medical Systems, Inc. · Mar 1983
ADHESIVE WOUND COVER FILM
K822080 · Hollister, Inc. · Oct 1982
K830593 · ENSURE DRESSING
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