Cleared Traditional

SEPRAGEL ENT BIORESORBABLE PACKING/STENT (K043035) - FDA 510(k) Clearance

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

K043035 · Genzyme Corporation · Ear, Nose, Throat device
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Jul 2005
Decision
250d
Days
Class 2
Risk

K043035 is an FDA 510(k) clearance for the SEPRAGEL ENT BIORESORBABLE PACKING/STENT. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Genzyme Corporation (Cambridge, US). The FDA issued a Cleared decision on July 11, 2005 after a review of 250 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K043035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2004
Decision Date July 11, 2005
Days to Decision 250 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
161d slower than avg
Panel avg: 89d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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.