Laryngoscope, Nasopharyngoscope
The laryngoscope/nasopharyngoscope is an endoscopic device used to visualize the larynx and nasopharynx for diagnostic assessment and therapeutic procedures in the ENT specialty. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing. The product code is EQN, regulated under 21 CFR 874.4760 in the Ear, Nose, Throat specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission.
Basic Information
- Product Code
- EQN
- Device Class
- FDA class 2
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150248 | ORL Video NasoPharyngo-Larngoscope | Jul 23, 2015 | Substantially Equivalent | JEDMED INSTRUMENT COMPANY |
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | Feb 21, 2014 | Substantially Equivalent | JEDMED INSTRUMENT CO. |
| K834172 | OP-CON SURG. INSTRUMENT #7 | Mar 06, 1984 | Substantially Equivalent | IMM ENTERPRISES LTD. |
| K831255 | LARYNGOSCOPE ATTACHMENT PH2000 | Sep 12, 1983 | Substantially Equivalent | EDER INSTRUMENT CO, INC. |
| K830888 | COOL-LITE FIBERCOPTIC LARYNGEAL EXAM | Apr 27, 1983 | Substantially Equivalent | NATIONAL MEDICAL TECHNOLOGY |
| K822525 | LARYNGOSCOPES RIGID | Sep 09, 1982 | Substantially Equivalent | KELLEHER CORP. |
| K821710 | NAGASHIMA NX-150F LIGHT SOURCE UNIT | Jun 25, 1982 | Substantially Equivalent | KELLEHER CORP. |
| K821709 | NAGASHIMA LIGHT SOURCE UNIT SL-5 | Jun 25, 1982 | Substantially Equivalent | KELLEHER CORP. |
| K821708 | NAGASHIMA LIGHT SOURCE UNIT SL-4 | Jun 25, 1982 | Substantially Equivalent | KELLEHER CORP. |
| K821707 | NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT | Jun 25, 1982 | Substantially Equivalent | KELLEHER CORP. |
| K821706 | NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL | Jun 25, 1982 | Substantially Equivalent | KELLEHER CORP. |
| K821269 | TRACHEOSTOMY CARE TRAYS | May 27, 1982 | Substantially Equivalent | INTERMED, INC. |
| K821182 | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | May 13, 1982 | Substantially Equivalent | MACHIDA AMERICA, INC. |
| K821181 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # | May 13, 1982 | Substantially Equivalent | MACHIDA AMERICA, INC. |
| K813297 | CONPHAR LARYNGOSCOPE | Jan 22, 1982 | Substantially Equivalent | CONPHAR, INC. |
| K812734 | MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P | Oct 19, 1981 | Substantially Equivalent | MACHIDA AMERICA, INC. |
| K811943 | MACHIDA NASOPHARYNGO-LARYNGOSCOPE | Jul 28, 1981 | Substantially Equivalent | MACHIDA AMERICA, INC. |
| K792222 | SHILEY LOW PRESSURE THIN-CUFFED TRACH. | Dec 18, 1979 | Substantially Equivalent | SHILEY, INC. |
| K782002 | TRACH-COLLAR | Dec 15, 1978 | Substantially Equivalent | KINETIC CONCEPTS, INC. |
| K781639 | SHILEY CRICOTHYROTOMY TUBE | Oct 24, 1978 | Substantially Equivalent | SHILEY, INC. |
| K770085 | ROBBETT MICROSURGICAL LARYNGOSCOPE | Jan 21, 1977 | Substantially Equivalent | EDWARD WECK, INC. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.