FDA product code FRQ: Tube, Levine
FRQ is the FDA product code for tube, levine. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FRQ, from 3 different applicants. The average 510(k) review took 99 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Tube, Levine |
| 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 |
Compare with all 510(k) review times · Search every FRQ clearance
Top FRQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mallinckrodt Medical | 1 | 1992-05-08 |
| Icn Pharmaceuticals, Inc. | 1 | 1991-12-18 |
| Pollak (Intl.), Ltd. | 1 | 1980-09-26 |
Most recent FRQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914887 | Mallinckrodt Medical | ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT | 1992-05-08 | 191 |
| K914530 | Icn Pharmaceuticals, Inc. | ICAN GT DRAINAGE BAG | 1991-12-18 | 68 |
| K802007 | Pollak (Intl.), Ltd. | PEDIWET=GUAZE IMPREGNATED WITH PETROL | 1980-09-26 | 37 |
Recalls for FRQ devices
openFDA lists no recalls for product code FRQ.
Frequently asked questions
What is FDA product code FRQ?
FRQ is the FDA product code for tube, levine. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is FRQ?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code FRQ?
Across 3 cleared submissions the average was 99 days from receipt to decision (median 68).
Which companies have the most FRQ clearances?
Mallinckrodt Medical (1); Icn Pharmaceuticals, Inc. (1); Pollak (Intl.), Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FRQ
- Run a recall and safety report across every FRQ manufacturer
- Watch product code FRQ 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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