Cleared Traditional

K012769 - MACROPORE ENT RECONSTRUCTION FILM (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012769 · Macropore Biosurgery, Inc. · Ear, Nose, Throat device
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Oct 2001
Decision
69d
Days
Class 2
Risk

K012769 is an FDA 510(k) clearance for the MACROPORE ENT RECONSTRUCTION FILM. Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by Macropore Biosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on October 25, 2001 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Macropore Biosurgery, Inc. devices

Submission Details

510(k) Number K012769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2001
Decision Date October 25, 2001
Days to Decision 69 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 89d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
Definition Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.