FDA product code FJQ: Connector, Shunt
FJQ is the FDA product code for connector, shunt. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FJQ, from 2 different applicants. The average 510(k) review took 122 days (median 143).
Classification
| Field | Value |
|---|---|
| Device name | Connector, Shunt |
| Device class | Class I |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FJQ clearance
Top FJQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quinton, Inc. | 2 | 1978-01-03 |
| Akcess Medical Products, Inc. | 1 | 1989-07-24 |
Most recent FJQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893679 | Akcess Medical Products, Inc. | SHUNT CONNECTORS | 1989-07-24 | 69 |
| K771422 | Quinton, Inc. | PATIENT BY-PASS | 1978-01-03 | 155 |
| K771429 | Quinton, Inc. | DISP. TEFLON CONNHCTOR | 1977-12-22 | 143 |
Recalls for FJQ devices
openFDA lists no recalls for product code FJQ.
Frequently asked questions
What is FDA product code FJQ?
FJQ is the FDA product code for connector, shunt. It is a Class I device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is FJQ?
Class I, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJQ?
Across 3 cleared submissions the average was 122 days from receipt to decision (median 143).
Which companies have the most FJQ clearances?
Quinton, Inc. (2); Akcess Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FJQ
- Run a recall and safety report across every FJQ manufacturer
- Watch product code FJQ 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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