Cleared Traditional

K070715 - NASOPORE EAR

K070715 is an FDA 510(k) clearance for NASOPORE EAR, manufactured by Polyganics B.V.,. The device is a Class 2 Ear, Nose, Throat device with product code NHB cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K070715 · Polyganics B.V., · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
54d
Days
Class 2
Risk

K070715 is an FDA 510(k) clearance for the NASOPORE EAR. Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by Polyganics B.V., (Groningen, NL). The FDA issued a Cleared decision on May 7, 2007 after a review of 54 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 Polyganics B.V., devices

FDA 510(k) Submission Details - K070715

510(k) Number K070715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2007
Decision Date May 07, 2007
Days to Decision 54 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
35d faster than avg
Panel avg: 89d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

All 9
Devices cleared under the same product code (NHB) and FDA review panel - the closest regulatory comparables to K070715.
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K012409 · Walter Lorenz Surgical, Inc. · Oct 2001