Cleared Traditional

RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM

K120280 · Acclarent, Inc. · Ear, Nose, Throat
Nov 2012
Decision
280d
Days
Class 1
Risk

About This 510(k) Submission

K120280 is an FDA 510(k) clearance for the RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Acclarent, Inc. (Menlo Park, US). The FDA issued a Cleared decision on November 5, 2012, 280 days after receiving the submission on January 30, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K120280 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2012
Decision Date November 05, 2012
Days to Decision 280 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420