FDA product code FKW: Tip, Vessel
FKW is the FDA product code for tip, vessel. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FKW, from 3 different applicants. The average 510(k) review took 39 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Tip, Vessel |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every FKW clearance
Top FKW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Akcess Medical Products, Inc. | 1 | 1989-06-08 |
| Quinton, Inc. | 1 | 1981-03-13 |
| Vickers America Medical Corp. | 1 | 1979-10-02 |
Most recent FKW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893438 | Akcess Medical Products, Inc. | T SERIES VESSEL TIPS | 1989-06-08 | 36 |
| K810257 | Quinton, Inc. | VESSEL TIPS, SIZES 13-18 | 1981-03-13 | 42 |
| K791645 | Vickers America Medical Corp. | VICKERS MEDICAL MODEL 112 TREONIC DC2 | 1979-10-02 | 40 |
Recalls for FKW devices
openFDA lists no recalls for product code FKW.
Frequently asked questions
What is FDA product code FKW?
FKW is the FDA product code for tip, vessel. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is FKW?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKW?
Across 3 cleared submissions the average was 39 days from receipt to decision (median 40).
Which companies have the most FKW clearances?
Akcess Medical Products, Inc. (1); Quinton, Inc. (1); Vickers America Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKW
- Run a recall and safety report across every FKW manufacturer
- Watch product code FKW 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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