Cleared Traditional

K153756 - Microlyte Ag

K153756 · Imbed Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
218d
Days
-
Risk

K153756 is an FDA 510(k) clearance for the Microlyte Ag. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Imbed Biosciences, Inc. (Fitchburg, US). The FDA issued a Cleared decision on August 4, 2016 after a review of 218 days - an extended review cycle.

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 Imbed Biosciences, Inc. devices

FDA 510(k) Submission Details - K153756

510(k) Number K153756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2015
Decision Date August 04, 2016
Days to Decision 218 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
103d slower than avg
Panel avg: 115d · This submission: 218d
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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