Cleared Traditional

HERMITEX SPONGE (K891324) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K891324 · Hermitage Hospital Products, Inc. · General & Plastic Surgery device
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Apr 1989
Decision
45d
Days
Class 1
Risk

K891324 is an FDA 510(k) clearance for the HERMITEX SPONGE. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Hermitage Hospital Products, Inc. (Niantic, US). The FDA issued a Cleared decision on April 27, 1989 after a review of 45 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hermitage Hospital Products, Inc. devices

Submission Details

510(k) Number K891324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1989
Decision Date April 27, 1989
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 K891324.
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
MELOLIN
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UNIFLEX
K820470 · Howmedica Corp. · Jun 1982
BONE-DRI SURGICAL SPONGE
K803125 · Howmedica Corp. · Jan 1981
BANDAGE COMPRESS 2, 3, 4
K770410 · Johnson & Johnson Professionals, Inc. · Jun 1977