Cleared Traditional

K163529 - ReliaTect Post-Op Dressing with CHG (8c...

K163529 · Avery Dennison Corporation · General & Plastic Surgery device
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Mar 2017
Decision
103d
Days
-
Risk

K163529 is an FDA 510(k) clearance for the ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing .... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Avery Dennison Corporation (Mentor, US). The FDA issued a Cleared decision on March 29, 2017 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Avery Dennison Corporation devices

FDA 510(k) Submission Details - K163529

510(k) Number K163529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date March 29, 2017
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 261
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