Cleared Traditional

K874553 - ENVISAN PASTE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K874553 · Marion Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 114d · 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.