LRC · Class I · 21 CFR 874.4420

FDA Product Code LRC: Instrument, Ent Manual Surgical

Leading manufacturers include United States Surgical, A Division of Tyco Healthc, Acclarent, Inc. and Intuit Medical Products, LLC.

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 Jun 08, 1994
DISPOSABLE NASAL SCISSOR
K942063
United States Surgical, A Division of Tyco Healthc
Ear, Nose, Throat · 40d
Cleared Jun 08, 1994
DISPOSABLE NASAL RONGEUR
K942064
United States Surgical, A Division of Tyco Healthc
Ear, Nose, Throat · 40d
Cleared Jun 06, 1994
DISPOSABLE ENT PUNCH
K942065
United States Surgical, A Division of Tyco Healthc
Ear, Nose, Throat · 38d

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.