Cleared Traditional

STERILE GAUZE PADS (K915591) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K915591 · Eagle Medical, Inc. · General & Plastic Surgery device
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Jan 1993
Decision
411d
Days
Class 1
Risk

K915591 is an FDA 510(k) clearance for the STERILE GAUZE PADS. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Eagle Medical, Inc. (Bridgeton, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 411 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Eagle Medical, Inc. devices

Submission Details

510(k) Number K915591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1991
Decision Date January 27, 1993
Days to Decision 411 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 115d · This submission: 411d
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

Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K915591.
TRICOTEX WOUND CONTACT LAYER DRESSING
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UNIFLEX
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BONE-DRI SURGICAL SPONGE
K803125 · Howmedica Corp. · Jan 1981
BANDAGE COMPRESS 2, 3, 4
K770410 · Johnson & Johnson Professionals, Inc. · Jun 1977