Cleared Traditional

K082276 - SYNTHEMED DEVICE

K082276 is an FDA 510(k) clearance for SYNTHEMED DEVICE, manufactured by Synthemed, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K082276 · Synthemed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
99d
Days
Class 1
Risk

K082276 is an FDA 510(k) clearance for the SYNTHEMED DEVICE. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Synthemed, Inc. (Iselin, US). The FDA issued a Cleared decision on November 18, 2008 after a review of 99 days - within the typical 510(k) review window.

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: 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 Synthemed, Inc. devices

FDA 510(k) Submission Details - K082276

510(k) Number K082276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date November 18, 2008
Days to Decision 99 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 90d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

LYA Device Classification - Class 1, General Controls

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 37
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K082276.
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
K122494 · Hemostasis, LLC · Mar 2013
NASAL/EPISTAXIS PACK
K113585 · Cogent Therapeutics, LLC · Apr 2012
SINEXUS SINUS STENT GEN 2, MODEL 1999-25
K092401 · Sinexus, Inc. · Nov 2009
QUIKCLOT NOSEBLEED
K080247 · Z-Medica Corporation · Feb 2008
ADVACOAT SINUS GEL AND STENT
K070496 · Carbylan Biosurgery · Mar 2007
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
K063308 · Carbylan Biosurgery · Dec 2006