FDA product code FKC: Clamp, Cannula
FKC is the FDA product code for clamp, cannula. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FKC. The average 510(k) review took 25 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Cannula |
| Device class | Class I |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
| Implant | Yes |
Compare with all 510(k) review times · Search every FKC clearance
Top FKC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quinton, Inc. | 1 | 1977-08-26 |
Most recent FKC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771419 | Quinton, Inc. | CANNULA CLAMP | 1977-08-26 | 25 |
Recalls for FKC devices
openFDA lists no recalls for product code FKC.
Frequently asked questions
What is FDA product code FKC?
FKC is the FDA product code for clamp, cannula. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is FKC?
Class I, regulation 21 CFR 876.5540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FKC?
Across 1 cleared submissions the average was 25 days from receipt to decision (median 25).
Which companies have the most FKC clearances?
Quinton, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKC
- Run a recall and safety report across every FKC manufacturer
- Watch product code FKC 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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