EQN — Laryngoscope, Nasopharyngoscope Class II
FDA product code EQN covers "Laryngoscope, Nasopharyngoscope", a Class II medical device regulated under 21 CFR 874.4760. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EQN
- Device Class
- Class II
- Regulation Number
- 874.4760
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252624 | karl storz endoscopy-america | KARL STORZ Laryngoscopes and Accessories | May 15, 2026 |
| K150248 | jedmed instrument | ORL Video NasoPharyngo-Larngoscope | July 23, 2015 |
| K132039 | jedmed instrument | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | February 21, 2014 |
| K834172 | imm enterprises | OP-CON SURG. INSTRUMENT #7 | March 6, 1984 |
| K831255 | eder instrument co | LARYNGOSCOPE ATTACHMENT PH2000 | September 12, 1983 |
| K830888 | national medical technology | COOL-LITE FIBERCOPTIC LARYNGEAL EXAM | April 27, 1983 |
| K822525 | kelleher | LARYNGOSCOPES RIGID | September 9, 1982 |
| K821710 | kelleher | NAGASHIMA NX-150F LIGHT SOURCE UNIT | June 25, 1982 |
| K821709 | kelleher | NAGASHIMA LIGHT SOURCE UNIT SL-5 | June 25, 1982 |
| K821706 | kelleher | NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL | June 25, 1982 |
| K821707 | kelleher | NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT | June 25, 1982 |
| K821708 | kelleher | NAGASHIMA LIGHT SOURCE UNIT SL-4 | June 25, 1982 |
| K821269 | intermed | TRACHEOSTOMY CARE TRAYS | May 27, 1982 |
| K821181 | machida america | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # | May 13, 1982 |
| K821182 | machida america | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | May 13, 1982 |
| K813297 | conphar | CONPHAR LARYNGOSCOPE | January 22, 1982 |
| K812734 | machida america | MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P | October 19, 1981 |
| K811943 | machida america | MACHIDA NASOPHARYNGO-LARYNGOSCOPE | July 28, 1981 |
| K792222 | shiley | SHILEY LOW PRESSURE THIN-CUFFED TRACH. | December 18, 1979 |
| K782002 | kinetic concepts | TRACH-COLLAR | December 15, 1978 |