Cleared Traditional

K002131 - LACTOSORB ETHMOID STENT
(FDA 510(k) Clearance)

K002131 · Walter Lorenz Surgical, Inc. · Ear, Nose, Throat
Apr 2001
Decision
273d
Days
Class 1
Risk

K002131 is an FDA 510(k) clearance for the LACTOSORB ETHMOID STENT, a Splint, Intranasal Septal (Class I — General Controls, product code LYA), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 13, 2001, 273 days after receiving the submission on July 14, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number K002131 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2000
Decision Date April 13, 2001
Days to Decision 273 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LYA — Splint, Intranasal Septal
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4780