LRCClass I

Instrument, Ent Manual Surgical

21 CFR 874.4420 / Ear, Nose, Throat

LRC is the FDA product code for Instrument, Ent Manual Surgical, a class I device type, regulated under 21 CFR 874.4420. As of 2026-09-10, FDA records hold 65 510(k) clearances under this code, the most recent dated 2023-05-25, and 5 recalls.

Classification record

Product code: LRC
Device name: Instrument, Ent Manual Surgical
Regulation: 21 CFR 874.4420
Device class: Class I
Review panel: Ear, Nose, Throat
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 65
Ingested recalls: 5

Clearances, product code LRC

By decision year

65 clearances under product code LRC with a decision year between 1987 and 2023, 2012 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code LRC by decision year
Year	Clearances
1987	2
1989	2
1992	1
1993	2
1994	6
1997	1
1999	1
2005	2
2006	1
2008	2
2009	1
2010	2
2011	6
2012	7
2013	7
2014	3
2015	6
2016	3
2017	2
2018	1
2019	1
2020	4
2022	1
2023	1

Applicants with the most clearances

Product code LRC

Applicants holding the most 510(k) clearances under product code LRC
Applicant	Clearances
Entellus Medical, Inc.	21
Acclarent Inc	13
Exmoor Plastics Limited	5
United States Surgical, A Division of Tyco Healthc	3
Intuit Medical Products, LLC	2
Medtronic Xomed, Inc.	2
Sinusys Corporation	2
3NT Medical Ltd.	1
ArthroCare Corporation	1
Entrigue Surgical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 200 companies shown, in name order