Cleared Traditional

K874553 - ENVISAN PASTE

K874553 is the FDA 510(k) clearance for ENVISAN PASTE by Marion Laboratories, Inc.. It is a Class 1 General & Plastic Surgery device (product code KOZ) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K874553 · Marion Laboratories, Inc. · General & Plastic Surgery device
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Dec 1987
Decision
44d
Days
Class 1
Risk

K874553 is an FDA 510(k) clearance for the ENVISAN PASTE. Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on December 18, 1987 after a review of 44 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 Marion Laboratories, Inc. devices

Submission Details

510(k) Number K874553 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 04, 1987
Decision Date December 18, 1987
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 K874553.
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
PHARMASEAL WOUND CARE DRESSING PAD
K870941 · American Pharmaseal Div. Ahsc · Mar 1987
COMFEEL POWDER
K834343 · Coloplast A/S · Nov 1984
HOLLISTER WOUND EXUDATE ABSORBER
K820160 · Hollister, Inc. · Apr 1982