Cleared Traditional

K820470 - UNIFLEX

K820470 is the FDA 510(k) clearance for UNIFLEX by Howmedica Corp.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K820470 · Howmedica Corp. · General & Plastic Surgery device

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Jun 1982

Decision

100d

Days

Class 1

Risk

K820470 is an FDA 510(k) clearance for the UNIFLEX. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 100 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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 Howmedica Corp. devices

Submission Details

510(k) Number	K820470 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 22, 1982
Decision Date	June 02, 1982
Days to Decision	100 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

15d faster than avg

Panel avg: 115d · This submission: 100d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	NAB Gauze / Sponge,nonresorbable For External Use
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 878.4014

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 - NAB Gauze / Sponge,nonresorbable For External Use

All 13

Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K820470.

COVER-ROLL STRETCH

K823879 · Beiersdorf, Inc. · Mar 1983

CONVERTORS DISPOSABLE DRESSING SPONGE

K822966 · American Hospital Supply Corp. · Nov 1982

MELOLIN

K821246 · Smith & Nephew, Inc. · Aug 1982

HOLLISTER ODOR ABSORBING WOUND PAD

K820464 · Hollister, Inc. · Mar 1982

TRIANGULAR BANDAGE

K811814 · Abco Dealers, Inc. · Jul 1981

BONE-DRI SURGICAL SPONGE

K803125 · Howmedica Corp. · Jan 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K820470

Howmedica Corp.

Mchenry, IL · US

Regulatory profile

373 submissions 325 cleared

87% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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