FDA product code FEW: Catheter, Malecot
FEW is the FDA product code for catheter, malecot. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under FEW, from 6 different applicants. The average 510(k) review took 132 days (median 120).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Malecot |
| Device class | Class II |
| Regulation | 21 CFR 876.5090 |
| 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 FEW clearance
Top FEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 1 | 2014-11-18 |
| C.R. Bard, Inc. | 1 | 2007-04-24 |
| Medical Device Technologies, Inc. | 1 | 1998-04-22 |
| Manan Medical Products, Inc. | 1 | 1996-03-26 |
| Technical Products, Inc. | 1 | 1995-11-06 |
1 more applicants have FEW clearances. See the full list in Caduvo.
Most recent FEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140085 | Cook Incorporated | UNIVERSA PERCULTANEOUS DRAINAGE CATHETER | 2014-11-18 | 309 |
| K070879 | C.R. Bard, Inc. | BARD MALECOT AND PEZZER DRAINS | 2007-04-24 | 25 |
| K981258 | Medical Device Technologies, Inc. | MANAN MALECOT BASKET DRAINAGE CATHETER | 1998-04-22 | 16 |
| K954147 | Manan Medical Products, Inc. | MANAN MALECOT BASKET DRAINAGE CATHETER | 1996-03-26 | 203 |
| K954116 | Technical Products, Inc. | SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP | 1995-11-06 | 109 |
Recalls for FEW devices
openFDA lists no recalls for product code FEW.
Frequently asked questions
What is FDA product code FEW?
FEW is the FDA product code for catheter, malecot. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel.
What device class is FEW?
Class II, regulation 21 CFR 876.5090. Typical premarket route: 510(k).
How long does a 510(k) take for product code FEW?
Across 6 cleared submissions the average was 132 days from receipt to decision (median 120).
Which companies have the most FEW clearances?
Cook Incorporated (1); C.R. Bard, Inc. (1); Medical Device Technologies, Inc. (1); Manan Medical Products, Inc. (1); Technical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FEW
- Run a recall and safety report across every FEW manufacturer
- Watch product code FEW 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times