Cleared Traditional

K901876 - INTRASITE CAVITY WOUND DRESSING (LABEL ...

K901876 is the FDA 510(k) clearance for INTRASITE CAVITY WOUND DRESSING (LABEL ... by Smith & Nephew United, Inc.. It is a Class 1 General & Plastic Surgery device (product code KOZ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K901876 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Jun 1990
Decision
63d
Days
Class 1
Risk

K901876 is an FDA 510(k) clearance for the INTRASITE CAVITY WOUND DRESSING (LABEL REVISION). Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on June 28, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4018 - 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 Smith & Nephew United, Inc. devices

Submission Details

510(k) Number K901876 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 26, 1990
Decision Date June 28, 1990
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4018
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 - KOZ Beads, Hydrophilic, For Wound Exudate Absorption

All 11
Devices cleared under the same product code (KOZ) and FDA review panel - the closest regulatory comparables to K901876.
CUTINOVA HYDRO
K905688 · Beiersdorf, Inc. · Apr 1991
DERMASORB WOUND CONTACT LAYER DRESSING
K903645 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
ALLEVYN DRESSING CLAIMS CHANGE
K904412 · Smith & Nephew United, Inc. · Oct 1990
INTRASITE CAVITY WOUND DRESSING
K895354 · Smith & Nephew United, Inc. · Nov 1989
ENVISAN PAD
K874552 · Marion Laboratories, Inc. · Jan 1988
DEBRISAN ABSORBENT PAD
K872453 · Pharmacia, Inc. · Jan 1988