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LRC — Instrument, Ent Manual Surgical Class I

FDA Device Classification

FDA product code LRC covers "Instrument, Ent Manual Surgical", a Class I medical device regulated under 21 CFR 874.4420. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LRC
Device Class
Class I
Regulation Number
874.4420
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230258excelentBB 8 Sinus Dilation KitMay 25, 2023
K212774intersect entVenSure LightGuideFebruary 4, 2022
K201398stryker entSINUSPRIME Dilation SystemOctober 15, 2020
K201115acclarentNext Generation Balloon Dilation SystemAugust 27, 2020
K201472fiagonVenSure Balloon Device, VenSure Nav Balloon DeviceAugust 26, 2020
K181546intuit medical productsDillard Nasal Balloon CatheterJanuary 3, 2020
K190525acclarentRELIEVA ULTIRRA Sinus Balloon CatheterMay 3, 2019
K1818383nt medicalSinusway Dilation SystemDecember 20, 2018
K172737m/s. meril life sciences private limitedMESIRE - Balloon Sinus Dilatation SystemDecember 12, 2017
K171687acclarentRelieva SpinPlus Nav Balloon Sinuplasty SystemSeptember 5, 2017
K161698acclarentRelieva UltirraNav Sinus Balloon CatheterOctober 24, 2016
K160770sinusys corporationVent-Os Sinus Dilation familyJune 29, 2016
K153341acclarentRelieva Scout Multi-Sinus Dilation SystemFebruary 12, 2016
K152121medtronic xomedNuVent EM Sinus Dilation SystemDecember 1, 2015
K152434entellus medicalXprESS Multi-Sinus Dilation SystemNovember 20, 2015
K152435entellus medicalPassAssist LED Light FiberNovember 20, 2015
K143738intuit medical productsDSS Sinusplasty Balloon CatheterAugust 27, 2015
K143541acclarentRelieva SpinPlus Balloon Sinuplasty SystemApril 22, 2015
K150172acclarentACCLARENT SE Inflation DeviceApril 7, 2015
K142252entellus medicalXprESS Multi-Sinus Dilation ToolOctober 17, 2014

FDA data resources