FDA product code BST: Curette, Biopsy, Bronchoscope (Non-Rigid)
BST is the FDA product code for curette, biopsy, bronchoscope (non-rigid). It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. Devices under BST reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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 | Curette, Biopsy, Bronchoscope (Non-Rigid) |
| 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 |
Recalls for BST devices
openFDA lists no recalls for product code BST.
Frequently asked questions
What is FDA product code BST?
BST is the FDA product code for curette, biopsy, bronchoscope (non-rigid). 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 BST?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code BST
- Run a recall and safety report across every BST manufacturer
- Watch product code BST 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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