Laryngoscope, Nasopharyngoscope
EQN is the FDA product code for Laryngoscope, Nasopharyngoscope, a class II device type, regulated under 21 CFR 874.4760. FDA's definition for this code reads: "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)". As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- EQN
- Device name
- Laryngoscope, Nasopharyngoscope
- FDA 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).
- Regulation
- 21 CFR 874.4760
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 22
- Ingested recalls
- 2
Clearances, product code EQN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1979 | 1 |
| 1981 | 2 |
| 1982 | 10 |
| 1983 | 2 |
| 1984 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code EQN| Applicant | Clearances |
|---|---|
| Kelleher Corp. | 6 |
| Machida America, Inc. | 4 |
| JEDMED Instrument Company | 2 |
| Shiley, Inc. | 2 |
| Conphar, Inc. | 1 |
| Eder Instrument Co, Inc. | 1 |
| Edward Weck, Inc. | 1 |
| Imm Enterprises, Ltd. | 1 |
| Intermed, Inc. | 1 |
| Karl Storz Endoscopy-America, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
