FDA product code FCB: Bag, Hemostatic
FCB is the FDA product code for bag, hemostatic. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. Devices under FCB reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for FCB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Hemostatic |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for FCB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-25.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code FCB?
FCB is the FDA product code for bag, hemostatic. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is FCB?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
Have FCB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-09-25.
Next steps
- Run an FDA pathway report with predicate devices for product code FCB
- Run a recall and safety report across every FCB manufacturer
- Watch product code FCB 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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