Cleared Traditional

K915357 - PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K915357 · Medtronic Vascular · General & Plastic Surgery device
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May 1992
Decision
183d
Days
Class 1
Risk

K915357 is an FDA 510(k) clearance for the PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH. Classified as Dressing, Wound, Hydrogel Without Drug And/or Biologic (product code NAE), Class I - General Controls.

Submitted by Medtronic Vascular (Brooklyn Center, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 183 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.

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Submission Details

510(k) Number K915357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date May 28, 1992
Days to Decision 183 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
69d slower than avg
Panel avg: 114d · This submission: 183d
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.