LRC · Class I · 21 CFR 874.4420

FDA Product Code LRC: Instrument, Ent Manual Surgical

Leading manufacturers include Entellus Medical, Inc., Acclarent, Inc. and Exmoor Plastics , Ltd..

65
Total
65
Cleared
102d
Avg days
1987
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Instrument, Ent Manual Surgical Devices (Product Code LRC)

65 devices
1–24 of 65
Cleared May 25, 2023
BB 8 Sinus Dilation Kit
K230258
Excelent, Inc.
Ear, Nose, Throat · 114d
Cleared Feb 04, 2022
VenSure LightGuide
K212774
Intersect Ent.
Ear, Nose, Throat · 156d
Cleared Oct 15, 2020
SINUSPRIME Dilation System
K201398
Stryker Ent
Ear, Nose, Throat · 140d
Cleared Aug 27, 2020
Next Generation Balloon Dilation System
K201115
Acclarent, Inc.
Ear, Nose, Throat · 122d
Cleared Aug 26, 2020
VenSure Balloon Device, VenSure Nav Balloon Device
K201472
Fiagon GmbH
Ear, Nose, Throat · 84d
Cleared Jan 03, 2020
Dillard Nasal Balloon Catheter
K181546
Intuit Medical Products, LLC
Ear, Nose, Throat · 570d
Cleared May 03, 2019
RELIEVA ULTIRRA Sinus Balloon Catheter
K190525
Acclarent, Inc.
Ear, Nose, Throat · 60d
Cleared Dec 20, 2018
Sinusway Dilation System
K181838
3nt Medical , Ltd.
Ear, Nose, Throat · 163d
Cleared Dec 12, 2017
MESIRE - Balloon Sinus Dilatation System
K172737
M/S. Meril Life Sciences Private Limited
Ear, Nose, Throat · 92d
Cleared Sep 05, 2017
Relieva SpinPlus Nav Balloon Sinuplasty System
K171687
Acclarent, Inc.
Ear, Nose, Throat · 90d
Cleared Oct 24, 2016
Relieva UltirraNav Sinus Balloon Catheter
K161698
Acclarent, Inc.
Ear, Nose, Throat · 126d
Cleared Jun 29, 2016
Vent-Os Sinus Dilation family
K160770
Sinusys Corporation
Ear, Nose, Throat · 100d
Cleared Feb 12, 2016
Relieva Scout Multi-Sinus Dilation System
K153341
Acclarent, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 01, 2015
NuVent EM Sinus Dilation System
K152121
Medtronic Xomed, Inc.
Ear, Nose, Throat · 124d
Cleared Nov 20, 2015
XprESS Multi-Sinus Dilation System
K152434
Entellus Medical, Inc.
Ear, Nose, Throat · 85d
Cleared Nov 20, 2015
PassAssist LED Light Fiber
K152435
Entellus Medical, Inc.
Ear, Nose, Throat · 85d
Cleared Aug 27, 2015
DSS Sinusplasty Balloon Catheter
K143738
Intuit Medical Products, LLC
Ear, Nose, Throat · 240d
Cleared Apr 22, 2015
Relieva SpinPlus Balloon Sinuplasty System
K143541
Acclarent, Inc.
Ear, Nose, Throat · 128d
Cleared Apr 07, 2015
ACCLARENT SE Inflation Device
K150172
Acclarent, Inc.
Ear, Nose, Throat · 71d
Cleared Oct 17, 2014
XprESS Multi-Sinus Dilation Tool
K142252
Entellus Medical, Inc.
Ear, Nose, Throat · 64d
Cleared Aug 07, 2014
PATHASSIST LED LIGHT FIBER
K141916
Entellus Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Feb 20, 2014
RELIEVA SCOUT SINUS DILATION SYSTEM
K140160
Acclarent, Inc.
Ear, Nose, Throat · 29d
Cleared Dec 20, 2013
PATHASSIST LIGHT SEEKER
K133563
Entellus Medical, Inc.
Ear, Nose, Throat · 30d
Cleared Dec 17, 2013
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
K130736
Helix Medical, LLC
Ear, Nose, Throat · 274d

About Product Code LRC - Regulatory Context

510(k) Submission Activity

65 total 510(k) submissions under product code LRC since 1987, with 65 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.