EQN · Laryngoscope, Nasopharyngoscope
Ear, Nose, Throat · 21 CFR 874.4760 · Class 2
Overview
| Product Code | EQN |
|---|---|
| Device Name | Laryngoscope, Nasopharyngoscope |
| Regulation | 21 CFR 874.4760 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150248 | ORL Video NasoPharyngo-Larngoscope | Jedmed Instrument Company | Jul 23, 2015 | SESE |
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | Jedmed Instrument Co. | Feb 21, 2014 | SESE |
| K834172 | OP-CON SURG. INSTRUMENT #7 | Imm Enterprises , Ltd. | Mar 6, 1984 | SESE |
| K831255 | LARYNGOSCOPE ATTACHMENT PH2000 | Eder Instrument Co, Inc. | Sep 12, 1983 | SESE |
| K830888 | COOL-LITE FIBERCOPTIC LARYNGEAL EXAM | National Medical Technology | Apr 27, 1983 | SESE |
| K822525 | LARYNGOSCOPES RIGID | Kelleher Corp. | Sep 9, 1982 | SESE |
| K821710 | NAGASHIMA NX-150F LIGHT SOURCE UNIT | Kelleher Corp. | Jun 25, 1982 | SESE |
| K821709 | NAGASHIMA LIGHT SOURCE UNIT SL-5 | Kelleher Corp. | Jun 25, 1982 | SESE |
| K821708 | NAGASHIMA LIGHT SOURCE UNIT SL-4 | Kelleher Corp. | Jun 25, 1982 | SESE |
| K821707 | NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT | Kelleher Corp. | Jun 25, 1982 | SESE |
| K821706 | NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL | Kelleher Corp. | Jun 25, 1982 | SESE |
| K821269 | TRACHEOSTOMY CARE TRAYS | Intermed, Inc. | May 27, 1982 | SESE |
| K821182 | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | Machida America, Inc. | May 13, 1982 | SESE |
| K821181 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # | Machida America, Inc. | May 13, 1982 | SESE |
| K813297 | CONPHAR LARYNGOSCOPE | Conphar, Inc. | Jan 22, 1982 | SESE |
| K812734 | MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P | Machida America, Inc. | Oct 19, 1981 | SESE |
| K811943 | MACHIDA NASOPHARYNGO-LARYNGOSCOPE | Machida America, Inc. | Jul 28, 1981 | SESE |
| K792222 | SHILEY LOW PRESSURE THIN-CUFFED TRACH. | Shiley, Inc. | Dec 18, 1979 | SESE |
| K782002 | TRACH-COLLAR | Kinetic Concepts, Inc. | Dec 15, 1978 | SESE |
| K781639 | SHILEY CRICOTHYROTOMY TUBE | Shiley, Inc. | Oct 24, 1978 | SESE |
Top Applicants
- Kelleher Corp. — 6 clearances
- Machida America, Inc. — 4 clearances
- Shiley, Inc. — 2 clearances
- National Medical Technology — 1 clearance
- Kinetic Concepts, Inc. — 1 clearance
