Product Code: LRC FDA class 1 21 CFR 874.4420

Instrument, Ent Manual Surgical

Ear, Nose, Throat

ENT manual surgical instruments are hand-held tools used by otolaryngologists during surgical procedures involving the ear, nose, and throat, including instruments for dissection, grasping, cutting, or manipulating tissue in these anatomical regions. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRC, regulated under 21 CFR 874.4420, within the Ear, Nose, and Throat medical specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

223

Registration Numbers

223

Unique Applicants

Years Active

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Basic Information

Product Code: LRC
Device Class: FDA class 1
Regulation Number: 874.4420
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 65 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K230258	BB 8 Sinus Dilation Kit	May 25, 2023	Substantially Equivalent	Excelent, Inc.
K212774	VenSure LightGuide	Feb 04, 2022	Substantially Equivalent	Intersect Ent.
K201398	SINUSPRIME Dilation System	Oct 15, 2020	Substantially Equivalent	Stryker Ent
K201115	Next Generation Balloon Dilation System	Aug 27, 2020	Substantially Equivalent	Acclarent, Inc.
K201472	VenSure Balloon Device, VenSure Nav Balloon Device	Aug 26, 2020	Substantially Equivalent	Fiagon GmbH
K181546	Dillard Nasal Balloon Catheter	Jan 03, 2020	Substantially Equivalent	Intuit Medical Products, LLC
K190525	RELIEVA ULTIRRA Sinus Balloon Catheter	May 03, 2019	Substantially Equivalent	Acclarent, Inc.
K181838	Sinusway Dilation System	Dec 20, 2018	Substantially Equivalent	3nt Medical , Ltd.
K172737	MESIRE - Balloon Sinus Dilatation System	Dec 12, 2017	Substantially Equivalent	M/S. Meril Life Sciences Private Limited
K171687	Relieva SpinPlus Nav Balloon Sinuplasty System	Sep 05, 2017	Substantially Equivalent	Acclarent, Inc.
K161698	Relieva UltirraNav Sinus Balloon Catheter	Oct 24, 2016	Substantially Equivalent	Acclarent, Inc.
K160770	Vent-Os Sinus Dilation family	Jun 29, 2016	Substantially Equivalent	Sinusys Corporation
K153341	Relieva Scout Multi-Sinus Dilation System	Feb 12, 2016	Substantially Equivalent	Acclarent, Inc.
K152121	NuVent EM Sinus Dilation System	Dec 01, 2015	Substantially Equivalent	Medtronic Xomed, Inc.
K152435	PassAssist LED Light Fiber	Nov 20, 2015	Substantially Equivalent	Entellus Medical, Inc.
K152434	XprESS Multi-Sinus Dilation System	Nov 20, 2015	Substantially Equivalent	Entellus Medical, Inc.
K143738	DSS Sinusplasty Balloon Catheter	Aug 27, 2015	Substantially Equivalent	Intuit Medical Products, LLC
K143541	Relieva SpinPlus Balloon Sinuplasty System	Apr 22, 2015	Substantially Equivalent	Acclarent, Inc.
K150172	ACCLARENT SE Inflation Device	Apr 07, 2015	Substantially Equivalent	Acclarent, Inc.
K142252	XprESS Multi-Sinus Dilation Tool	Oct 17, 2014	Substantially Equivalent	Entellus Medical, Inc.
K141916	PATHASSIST LED LIGHT FIBER	Aug 07, 2014	Substantially Equivalent	Entellus Medical, Inc.
K140160	RELIEVA SCOUT SINUS DILATION SYSTEM	Feb 20, 2014	Substantially Equivalent	Acclarent, Inc.
K133563	PATHASSIST LIGHT SEEKER	Dec 20, 2013	Substantially Equivalent	Entellus Medical, Inc.
K130736	BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS	Dec 17, 2013	Substantially Equivalent	Helix Medical, LLC
K133016	VENT-OS SINUS DILATION SYSTEM	Dec 09, 2013	Substantially Equivalent	Sinusys Corporation
K132297	EM SINUS DILATION SYSTEM	Nov 05, 2013	Substantially Equivalent	Medtronic Xomed, Inc.
K132440	XPRESS MULTI-SINUS DILATION TOOL	Oct 04, 2013	Substantially Equivalent	Entellus Medical, Inc.
K131709	SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT	Oct 04, 2013	Substantially Equivalent	Arthrocare Corp.
K130503	PATHASSIST LED LIGHT FIBER	Jun 11, 2013	Substantially Equivalent	Entellus Medical, Inc.
K120280	RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM	Nov 05, 2012	Substantially Equivalent	Acclarent, Inc.
K121351	SINUS DILATION SYSTEM	Aug 29, 2012	Substantially Equivalent	Entrigue Surgical, Inc.
K121943	XPRESS MULTI-SINUS DILATION TOOL	Aug 22, 2012	Substantially Equivalent	Entellus Medical, Inc.
K121174	XPRESS MULTI-SINUS DILATION TOOL	May 17, 2012	Substantially Equivalent	Entellus Medical, Inc.
K120962	PATHASSIST LIGHT FIBER	Apr 27, 2012	Substantially Equivalent	Entellus Medical, Inc.
K120735	PATHASSIT LIGHT SEEKER	Apr 02, 2012	Substantially Equivalent	Entellus Medical, Inc.
K113522	PATHASSIST LIGHT SEEKER	Jan 27, 2012	Substantially Equivalent	Entellus Medical, Inc.
K112506	XPRESS MULTI-SINUS DILATION TOOL	Dec 21, 2011	Substantially Equivalent	Entellus Medical, Inc.
K111875	RELIEVA SPIN SINUS DILATION SYSTEM	Oct 11, 2011	Substantially Equivalent	Acclarent, Inc.
K111763	PATHASSIST LIGHT FIBER	Sep 15, 2011	Substantially Equivalent	Entellus Medical, Inc.
K111254	RELIEVA SOLO ELITE SINUS BALLOON CATHETER	Aug 22, 2011	Substantially Equivalent	Acclarent, Inc.
K110739	ENTELLUS MEDICAL SINUS GUIDEWIRE	Jun 14, 2011	Substantially Equivalent	Entellus Medical, Inc.
K110158	ILLUMINATING SINUS SEEKER	Jun 07, 2011	Substantially Equivalent	Entellus Medical, Inc.
K102003	XPRESS BALLOON DEVICE	Oct 22, 2010	Substantially Equivalent	Entellus Medical, Inc.
K093007	ENTELLUS MEDICAL BALLOON DEVICE	Feb 05, 2010	Substantially Equivalent	Entellus Medical, Inc.
K091681	FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)	Jul 08, 2009	Substantially Equivalent	Entellus Medical, Inc.
K081542	MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM	Jun 27, 2008	Substantially Equivalent	Entellus Medical, Inc.
K072302	ENTELLUS MEDICAL RS-SERIES SYSTEM	Apr 08, 2008	Substantially Equivalent	Entellus Medical, Inc.
K061903	RELIEVA SINUS BALLOON CATHETER	Aug 18, 2006	Substantially Equivalent	Acclarent, Inc.
K052198	RELIEVA SINUS BALLOON INFLATION DEVICE	Aug 31, 2005	Substantially Equivalent	Acclarent, Inc.
K043527	RELIEVA SINUS BALLOON DILATION CATHETER	Apr 05, 2005	Substantially Equivalent	Exploramed Nc1, Inc.
K990366	EXMOOR SUCTION CLEARANCE KIT	Mar 05, 1999	Substantially Equivalent	Exmoor Plastics , Ltd.
K970018	FAST TRACT TRANSTRACHEAL PROCEDURE KIT	Mar 28, 1997	Substantially Equivalent	L.W. Ward and Assoc., Inc.
K942745	EXMOOR SINGLE USE MYRINGOTOMES	Sep 02, 1994	Substantially Equivalent	Exmoor Plastics , Ltd.
K942746	SUCKER ENDS (ZOELLNER)	Aug 24, 1994	Substantially Equivalent	Exmoor Plastics , Ltd.
K942064	DISPOSABLE NASAL RONGEUR	Jun 08, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K942063	DISPOSABLE NASAL SCISSOR	Jun 08, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K942065	DISPOSABLE ENT PUNCH	Jun 06, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K933770	FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE	Mar 23, 1994	Substantially Equivalent	Mahe-Medizintechnik
K931793	SYMBIOSIS ENT SURGICAL INSTRUMENTS	Jul 22, 1993	Substantially Equivalent	Symbiosis Corp.
K930292	HOUSE-BELLUCCI ALLIGATOR SCISSORS	Mar 19, 1993	Substantially Equivalent	Thomasville Medical Assoc.
K920988	ATMOS MIRROR WARMER	May 15, 1992	Substantially Equivalent	Jedmed Instrument Co.
K892504	'EXMOOR' SINGLE USE SUCTION TUBE	Jun 22, 1989	Substantially Equivalent	Exmoor Plastics , Ltd.
K884631	FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)	Mar 22, 1989	Substantially Equivalent	Xomed, Inc.
K873044	POREX OTOLOGY INSTRUMENTS	Sep 04, 1987	Substantially Equivalent	Porex Medical
K864938	'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR	Mar 23, 1987	Substantially Equivalent	Exmoor Plastics , Ltd.