Cleared Traditional

DUODERM HYDROCOLLOID GEL (K931618) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K931618 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
252d
Days
Class 1
Risk

K931618 is an FDA 510(k) clearance for the DUODERM HYDROCOLLOID GEL. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on December 10, 1993 after a review of 252 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4022 - 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K931618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date December 10, 1993
Days to Decision 252 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAE Dressing, Wound, Hydrogel Without Drug And/or Biologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4022
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.