FDA product code FBW: Filiform And Filiform Follower
FBW is the FDA product code for filiform and filiform follower. It is a Class I device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FBW. The average 510(k) review took 91 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Filiform And Filiform Follower |
| Device class | Class I |
| Regulation | 21 CFR 876.5520 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FBW clearance
Top FBW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 1 | 1991-09-25 |
Most recent FBW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K912839 | Baxter Healthcare Corp | LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE | 1991-09-25 | 91 |
Recalls for FBW devices
openFDA lists no recalls for product code FBW.
Frequently asked questions
What is FDA product code FBW?
FBW is the FDA product code for filiform and filiform follower. It is a Class I device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel.
What device class is FBW?
Class I, regulation 21 CFR 876.5520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FBW?
Across 1 cleared submissions the average was 91 days from receipt to decision (median 91).
Which companies have the most FBW clearances?
Baxter Healthcare Corp (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FBW
- Run a recall and safety report across every FBW manufacturer
- Watch product code FBW 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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