FDA product code ENZ: Telescope, Laryngeal-Bronchial
ENZ is the FDA product code for telescope, laryngeal-bronchial. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under ENZ, from 3 different applicants. The average 510(k) review took 180 days (median 81).
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).
Classification
| Field | Value |
|---|---|
| Device name | Telescope, Laryngeal-Bronchial |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every ENZ clearance
Top ENZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 1 | 1995-09-15 |
| Karl Storz Endoskop GmbH | 1 | 1994-10-14 |
| National Medical Technology | 1 | 1979-07-24 |
Most recent ENZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944032 | Jedmed Instrument Co. | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | 1995-09-15 | 394 |
| K943904 | Karl Storz Endoskop GmbH | RIGID TELESCOPES | 1994-10-14 | 64 |
| K790845 | National Medical Technology | DUALUME LARYNGEAL EXAMINATION TELESCOPE | 1979-07-24 | 81 |
Recalls for ENZ devices
openFDA lists no recalls for product code ENZ.
Frequently asked questions
What is FDA product code ENZ?
ENZ is the FDA product code for telescope, laryngeal-bronchial. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is ENZ?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code ENZ?
Across 3 cleared submissions the average was 180 days from receipt to decision (median 81).
Which companies have the most ENZ clearances?
Jedmed Instrument Co. (1); Karl Storz Endoskop GmbH (1); National Medical Technology (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ENZ
- Run a recall and safety report across every ENZ manufacturer
- Watch product code ENZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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