FDA product code FFA: Tube, Drainage, Suprapubic
FFA is the FDA product code for tube, drainage, suprapubic. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FFA, from 3 different applicants. The average 510(k) review took 79 days (median 81). FDA has posted 10 recalls for FFA devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Drainage, Suprapubic |
| 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 FFA clearance
Top FFA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 1 | 1994-12-08 |
| New England Surgical Instrument Corp. | 1 | 1987-02-24 |
| Concept, Inc. | 1 | 1983-11-07 |
Most recent FFA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944290 | Boston Scientific Corp | CATHETERS, BILIARY CATHETERS, UROLOGICAL | 1994-12-08 | 97 |
| K864770 | New England Surgical Instrument Corp. | SUCTION TUBE | 1987-02-24 | 81 |
| K833061 | Concept, Inc. | C-FLEX PENROSE DRAINAGE TUBE | 1983-11-07 | 59 |
Recalls for FFA devices
10 product recalls in 3 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-07-18.
| Year | Recalls |
|---|---|
| 2024 | 5 |
Frequently asked questions
What is FDA product code FFA?
FFA is the FDA product code for tube, drainage, suprapubic. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel.
What device class is FFA?
Class II, regulation 21 CFR 876.5090. Typical premarket route: 510(k).
How long does a 510(k) take for product code FFA?
Across 3 cleared submissions the average was 79 days from receipt to decision (median 81).
Which companies have the most FFA clearances?
Boston Scientific Corp (1); New England Surgical Instrument Corp. (1); Concept, Inc. (1).
Have FFA devices been recalled?
Yes: 10 product recalls across 3 recall events; the most recent began 2024-07-18.
Next steps
- Run an FDA pathway report with predicate devices for product code FFA
- Run a recall and safety report across every FFA manufacturer
- Watch product code FFA 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