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.
Cleared Devices (65)
| 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 |
| K141916 | PATHASSIST LED LIGHT FIBER | Entellus Medical, Inc. | Aug 7, 2014 | SESE |
| K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM | Acclarent, Inc. | Feb 20, 2014 | SESE |
| K133563 | PATHASSIST LIGHT SEEKER | Entellus Medical, Inc. | Dec 20, 2013 | SESE |
| K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS | Helix Medical, LLC | Dec 17, 2013 | SESE |
| K133016 | VENT-OS SINUS DILATION SYSTEM | Sinusys Corporation | Dec 9, 2013 | SESE |
| K132297 | EM SINUS DILATION SYSTEM | Medtronic Xomed, Inc. | Nov 5, 2013 | SESE |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | Oct 4, 2013 | SESE |
| K131709 | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT | Arthrocare Corp. | Oct 4, 2013 | SESE |
| K130503 | PATHASSIST LED LIGHT FIBER | Entellus Medical, Inc. | Jun 11, 2013 | SESE |
| K120280 | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM | Acclarent, Inc. | Nov 5, 2012 | SESE |
| K121351 | SINUS DILATION SYSTEM | Entrigue Surgical, Inc. | Aug 29, 2012 | SESE |
| K121943 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | Aug 22, 2012 | SESE |
| K121174 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | May 17, 2012 | SESE |
| K120962 | PATHASSIST LIGHT FIBER | Entellus Medical, Inc. | Apr 27, 2012 | SESE |
| K120735 | PATHASSIT LIGHT SEEKER | Entellus Medical, Inc. | Apr 2, 2012 | SESE |
| K113522 | PATHASSIST LIGHT SEEKER | Entellus Medical, Inc. | Jan 27, 2012 | SESE |
| K112506 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | Dec 21, 2011 | SESE |
| K111875 | RELIEVA SPIN SINUS DILATION SYSTEM | Acclarent, Inc. | Oct 11, 2011 | SESE |
| K111763 | PATHASSIST LIGHT FIBER | Entellus Medical, Inc. | Sep 15, 2011 | SESE |
| K111254 | RELIEVA SOLO ELITE SINUS BALLOON CATHETER | Acclarent, Inc. | Aug 22, 2011 | SESE |
| K110739 | ENTELLUS MEDICAL SINUS GUIDEWIRE | Entellus Medical, Inc. | Jun 14, 2011 | SESE |
| K110158 | ILLUMINATING SINUS SEEKER | Entellus Medical, Inc. | Jun 7, 2011 | SESE |
| K102003 | XPRESS BALLOON DEVICE | Entellus Medical, Inc. | Oct 22, 2010 | SESE |
| K093007 | ENTELLUS MEDICAL BALLOON DEVICE | Entellus Medical, Inc. | Feb 5, 2010 | SESE |
| K091681 | FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) | Entellus Medical, Inc. | Jul 8, 2009 | SESE |
| K081542 | MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM | Entellus Medical, Inc. | Jun 27, 2008 | SESE |
| K072302 | ENTELLUS MEDICAL RS-SERIES SYSTEM | Entellus Medical, Inc. | Apr 8, 2008 | SESE |
| K061903 | RELIEVA SINUS BALLOON CATHETER | Acclarent, Inc. | Aug 18, 2006 | SESE |
| K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE | Acclarent, Inc. | Aug 31, 2005 | SESE |
| K043527 | RELIEVA SINUS BALLOON DILATION CATHETER | Exploramed Nc1, Inc. | Apr 5, 2005 | SESE |
| K990366 | EXMOOR SUCTION CLEARANCE KIT | Exmoor Plastics , Ltd. | Mar 5, 1999 | SESE |
| K970018 | FAST TRACT TRANSTRACHEAL PROCEDURE KIT | L.W. Ward and Assoc., Inc. | Mar 28, 1997 | SESE |
| K942745 | EXMOOR SINGLE USE MYRINGOTOMES | Exmoor Plastics , Ltd. | Sep 2, 1994 | SESE |
| K942746 | SUCKER ENDS (ZOELLNER) | Exmoor Plastics , Ltd. | Aug 24, 1994 | SESE |
| K942064 | DISPOSABLE NASAL RONGEUR | United States Surgical, A Division of Tyco Healthc | Jun 8, 1994 | SESE |
| K942063 | DISPOSABLE NASAL SCISSOR | United States Surgical, A Division of Tyco Healthc | Jun 8, 1994 | SESE |
| K942065 | DISPOSABLE ENT PUNCH | United States Surgical, A Division of Tyco Healthc | Jun 6, 1994 | SESE |
| K933770 | FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE | Mahe-Medizintechnik | Mar 23, 1994 | SESE |
| K931793 | SYMBIOSIS ENT SURGICAL INSTRUMENTS | Symbiosis Corp. | Jul 22, 1993 | SESE |
| K930292 | HOUSE-BELLUCCI ALLIGATOR SCISSORS | Thomasville Medical Assoc. | Mar 19, 1993 | SESE |
| K920988 | ATMOS MIRROR WARMER | Jedmed Instrument Co. | May 15, 1992 | SESE |
| K892504 | 'EXMOOR' SINGLE USE SUCTION TUBE | Exmoor Plastics , Ltd. | Jun 22, 1989 | SESE |
| K884631 | FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) | Xomed, Inc. | Mar 22, 1989 | SESE |
| K873044 | POREX OTOLOGY INSTRUMENTS | Porex Medical | Sep 4, 1987 | SESE |
| K864938 | 'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR | Exmoor Plastics , Ltd. | Mar 23, 1987 | 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
- Sinusys Corporation — 2 clearances
