Cleared Traditional

K012532 - SEPRAGEL SINUS

K012532 is the FDA 510(k) clearance for SEPRAGEL SINUS by Genzyme Corp.. It is a Class 1 Ear, Nose, Throat device (product code LYA) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K012532 · Genzyme Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
85d
Days
Class 1
Risk

K012532 is an FDA 510(k) clearance for the SEPRAGEL SINUS. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Genzyme Corp. (Ridgefield, US). The FDA issued a Cleared decision on October 30, 2001 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - 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 Genzyme Corp. devices

Submission Details

510(k) Number K012532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date October 30, 2001
Days to Decision 85 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
4d faster than avg
Panel avg: 89d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYA Splint, Intranasal Septal

All 14
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K012532.
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · Medtronic, Inc. · Oct 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · ArthroCare Corporation · Jun 2014
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · Medtronic Xomed, Inc. · Sep 2004
LACTOSORB ETHMOID STENT
K002131 · Walter Lorenz Surgical, Inc. · Apr 2001
NASAL SEPTAL SPLINT
K952207 · Smith & Nephew Richards, Inc. · Jun 1995
BIVONA NASAL TURBINATE STENT
K935053 · Bivona Medical Technologies · Jul 1994