Cleared Traditional

K760469 - CLEANSING AGENT, NEW WOUND (DEBRISSU) (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K760469 · Pharmaseal Laboratories · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1976
Decision
119d
Days
Class 1
Risk

K760469 is an FDA 510(k) clearance for the CLEANSING AGENT, NEW WOUND (DEBRISSU). Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Pharmaseal Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 16, 1976 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmaseal Laboratories devices

Submission Details

510(k) Number K760469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1976
Decision Date December 16, 1976
Days to Decision 119 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
5d slower than avg
Panel avg: 114d · This submission: 119d
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.