Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
Bronchoscope Brush Sheath and Aspirating Tubing are accessory components used with bronchoscopes to facilitate specimen collection and fluid aspiration from the airways during diagnostic or therapeutic bronchoscopic procedures. They are classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission. The product code is JEJ, regulated under 21 CFR 874.4680, within the Ear, Nose, and Throat medical specialty, and is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JEJ
- 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 2 510(k) clearances via K numbers.