LRC · Instrument, Ent Manual Surgical
Ear, Nose, Throat · 21 CFR 874.4420 · Class 1
Overview
| Product Code | LRC |
|---|---|
| Device Name | Instrument, Ent Manual Surgical |
| Regulation | 21 CFR 874.4420 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
Recent Cleared Devices (20 of 65)
Showing 20 most recent of 65 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | May 25, 2023 | SESE |
| K212774 | VenSure LightGuide | Intersect Ent. | Feb 4, 2022 | SESE |
| K201398 | SINUSPRIME Dilation System | Stryker Ent | Oct 15, 2020 | SESE |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | Aug 27, 2020 | SESE |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | Aug 26, 2020 | SESE |
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | Jan 3, 2020 | SESE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | May 3, 2019 | SESE |
| K181838 | Sinusway Dilation System | 3nt Medical , Ltd. | Dec 20, 2018 | SESE |
| K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | Dec 12, 2017 | SESE |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | Sep 5, 2017 | SESE |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | Oct 24, 2016 | SESE |
| K160770 | Vent-Os Sinus Dilation family | Sinusys Corporation | Jun 29, 2016 | SESE |
| K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | Feb 12, 2016 | SESE |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | Dec 1, 2015 | SESE |
| K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | Nov 20, 2015 | SESE |
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | Nov 20, 2015 | SESE |
| K143738 | DSS Sinusplasty Balloon Catheter | Intuit Medical Products, LLC | Aug 27, 2015 | SESE |
| K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | Apr 22, 2015 | SESE |
| K150172 | ACCLARENT SE Inflation Device | Acclarent, Inc. | Apr 7, 2015 | SESE |
| K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | Oct 17, 2014 | SESE |
Top Applicants
- Entellus Medical, Inc. — 21 clearances
- Acclarent, Inc. — 13 clearances
- Exmoor Plastics , Ltd. — 5 clearances
- United States Surgical, A Division of Tyco Healthc — 3 clearances
- Intuit Medical Products, LLC — 2 clearances
