FDA product code BWL: Apparatus, Electronanesthesia
BWL is the FDA product code for apparatus, electronanesthesia. It is a Class III device, regulated under 21 CFR 868.5400 and reviewed by the Anesthesiology panel. Devices under BWL reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Electronanesthesia |
| Device class | Class III |
| Regulation | 21 CFR 868.5400 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | PMA |
Recalls for BWL devices
openFDA lists no recalls for product code BWL.
Frequently asked questions
What is FDA product code BWL?
BWL is the FDA product code for apparatus, electronanesthesia. It is a Class III device, regulated under 21 CFR 868.5400 and reviewed by the Anesthesiology panel.
What device class is BWL?
Class III, regulation 21 CFR 868.5400. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code BWL
- Run a recall and safety report across every BWL manufacturer
- Watch product code BWL 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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