Telescope, Laryngeal-Bronchial
The laryngeal-bronchial telescope is a rigid or semi-rigid optical instrument used to visualize the larynx and bronchial passages for diagnostic and therapeutic purposes in the ENT setting. It is classified as FDA Class 2, indicating moderate risk; manufacturers must submit a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is ENZ, regulated under 21 CFR 874.4680 in the Ear, Nose, Throat specialty. This device is eligible for third-party review. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission.
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Basic Information
- Product Code
- ENZ
- Device Class
- FDA class 2
- Regulation Number
- 874.4680
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944032 | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | Sep 15, 1995 | Substantially Equivalent | Jedmed Instrument Co. |
| K943904 | RIGID TELESCOPES | Oct 14, 1994 | Substantially Equivalent | Karl Storz Endoskop GmbH |
| K790845 | DUALUME LARYNGEAL EXAMINATION TELESCOPE | Jul 24, 1979 | Substantially Equivalent | National Medical Technology |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.