FDA product code FAQ: Bag, Urine Collection, Leg, For External Use, Sterile
FAQ is the FDA product code for bag, urine collection, leg, for external use, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 18 510(k) submissions under FAQ, from 14 different applicants. The average 510(k) review took 65 days (median 48). FDA has posted 7 recalls for FAQ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Urine Collection, Leg, For External Use, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top FAQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Convatec, A Division of E.R. Squibb & Sons | 3 | 1996-07-18 |
| Coloplast Corp. | 2 | 1995-12-29 |
| C.R. Bard, Inc. | 2 | 1992-12-17 |
| Custom Pack Reliability | 1 | 1996-03-28 |
| Nelmed Corp. | 1 | 1994-11-02 |
9 more applicants have FAQ clearances. See the full list in Caduvo.
Most recent FAQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962604 | Convatec, A Division of E.R. Squibb & Sons | PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING | 1996-07-18 | 16 |
| K960217 | Custom Pack Reliability | CPR URINE BAG | 1996-03-28 | 72 |
| K955609 | Coloplast Corp. | CONVEEN URINE BAG - STERILE | 1995-12-29 | 21 |
| K953767 | Convatec, A Division of E.R. Squibb & Sons | PROSYS BEDSIDE DRAINAGE BAG | 1995-12-20 | 131 |
| K953783 | Coloplast Corp. | CONVEEN LEG BAG STRAP | 1995-09-13 | 30 |
Recalls for FAQ devices
7 product recalls in 4 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-10-19.
| Year | Recalls |
|---|---|
| 2023 | 3 |
Frequently asked questions
What is FDA product code FAQ?
FAQ is the FDA product code for bag, urine collection, leg, for external use, sterile. It is a Class I device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is FAQ?
Class I, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FAQ?
Across 18 cleared submissions the average was 65 days from receipt to decision (median 48).
Which companies have the most FAQ clearances?
Convatec, A Division of E.R. Squibb & Sons (3); Coloplast Corp. (2); C.R. Bard, Inc. (2); Custom Pack Reliability (1); Nelmed Corp. (1).
Have FAQ devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2023-10-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FAQ
- Run a recall and safety report across every FAQ manufacturer
- Watch product code FAQ 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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