Cleared Traditional

K003855 - HYALOMATRIX CO

K003855 is an FDA 510(k) clearance for HYALOMATRIX CO, manufactured by Fidia Advanced Biopolymers Srl. The device is a Class 2 Ear, Nose, Throat device with product code KHJ cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K003855 · Fidia Advanced Biopolymers Srl · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
202d
Days
Class 2
Risk

K003855 is an FDA 510(k) clearance for the HYALOMATRIX CO. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Fidia Advanced Biopolymers Srl (Abano Terme, IT). The FDA issued a Cleared decision on July 3, 2001 after a review of 202 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.

View all Fidia Advanced Biopolymers Srl devices

FDA 510(k) Submission Details - K003855

510(k) Number K003855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2000
Decision Date July 03, 2001
Days to Decision 202 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
113d slower than avg
Panel avg: 89d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHJ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

All 10
Devices cleared under the same product code (KHJ) and FDA review panel - the closest regulatory comparables to K003855.
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MEROGEL OTOLOGIC PACK
K001148 · Xomed, Inc. · Jun 2000
EPIFILM OTOLOGIC LAMINA
K982870 · Xomed, Inc. · Nov 1998
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K982294 · Xomed, Inc. · Sep 1998
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
K972700 · Exmoor Plastics , Ltd. · Jul 1998