FDA product code EXF: Bag, Bile Collecting
EXF is the FDA product code for bag, bile collecting. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under EXF, from 7 different applicants. The average 510(k) review took 103 days (median 69). FDA has posted 3 recalls for EXF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Bile Collecting |
| Device class | Class II |
| Regulation | 21 CFR 876.5010 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EXF clearance
Top EXF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Manan Medical Products, Inc. | 2 | 1997-03-13 |
| Uresil Corp. | 2 | 1990-09-12 |
| Merit Medical Systems, Inc. | 1 | 2000-12-11 |
| Remington Medical, Inc. | 1 | 1999-08-12 |
| Medical Device Technologies, Inc. | 1 | 1998-01-30 |
2 more applicants have EXF clearances. See the full list in Caduvo.
Most recent EXF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003078 | Merit Medical Systems, Inc. | MERIT DRAINAGE DEPOT | 2000-12-11 | 69 |
| K990428 | Remington Medical, Inc. | DRAINAGE BAG | 1999-08-12 | 182 |
| K980005 | Medical Device Technologies, Inc. | MANAN D BAG | 1998-01-30 | 28 |
| K961986 | Manan Medical Products, Inc. | MANAN D BAG | 1997-03-13 | 296 |
| K963849 | Manan Medical Products, Inc. | MANAN D BAG | 1996-12-13 | 79 |
Recalls for EXF devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-11-03.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code EXF?
EXF is the FDA product code for bag, bile collecting. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel.
What device class is EXF?
Class II, regulation 21 CFR 876.5010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXF?
Across 9 cleared submissions the average was 103 days from receipt to decision (median 69).
Which companies have the most EXF clearances?
Manan Medical Products, Inc. (2); Uresil Corp. (2); Merit Medical Systems, Inc. (1); Remington Medical, Inc. (1); Medical Device Technologies, Inc. (1).
Have EXF devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2023-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code EXF
- Run a recall and safety report across every EXF manufacturer
- Watch product code EXF 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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