FDA product code FFL: Dislodger, Stone, Basket, Ureteral, Metal
FFL is the FDA product code for dislodger, stone, basket, ureteral, metal. It is a Class II device, regulated under 21 CFR 876.4680 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 52 510(k) submissions under FFL, from 30 different applicants. The average 510(k) review took 80 days (median 60). FDA has posted 10 recalls for FFL devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dislodger, Stone, Basket, Ureteral, Metal |
| Device class | Class II |
| Regulation | 21 CFR 876.4680 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for FFL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 50 |
| 2019 | 1 | 140 |
Compare with all 510(k) review times · Search every FFL clearance
Top FFL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Annex Medical, Inc. | 10 | 1995-10-26 |
| Van-Tec, Inc. | 10 | 1987-06-17 |
| Percutaneous Systems, Inc. | 2 | 2011-05-16 |
| Olympus America, Inc. | 2 | 1996-07-31 |
| C.R. Bard, Inc. | 2 | 1996-05-28 |
25 more applicants have FFL clearances. See the full list in Caduvo.
Most recent FFL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190492 | Calcula Technologies, Inc. | Peralta Stone Removal Catheter | 2019-07-18 | 140 |
| K172299 | Ths International, Inc. D/B/A Accordion Medical | Accordion Piccolo Stone Management Device | 2017-09-19 | 50 |
| K102887 | Percutaneous Systems, Inc. | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 | 2011-05-16 | 228 |
| K082803 | Percutaneous Systems, Inc. | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 | 2008-11-13 | 50 |
| K052048 | Percutaneous Systems, Incorporated | ACCORDION | 2005-09-13 | 46 |
Recalls for FFL devices
10 product recalls in 7 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-06-22.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code FFL?
FFL is the FDA product code for dislodger, stone, basket, ureteral, metal. It is a Class II device, regulated under 21 CFR 876.4680 and reviewed by the Gastroenterology and Urology panel.
What device class is FFL?
Class II, regulation 21 CFR 876.4680. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFL?
Across 52 cleared submissions the average was 80 days from receipt to decision (median 60).
Which companies have the most FFL clearances?
Annex Medical, Inc. (10); Van-Tec, Inc. (10); Percutaneous Systems, Inc. (2); Olympus America, Inc. (2); C.R. Bard, Inc. (2).
Have FFL devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2023-06-22.
Next steps
- Run an FDA pathway report with predicate devices for product code FFL
- Run a recall and safety report across every FFL manufacturer
- Watch product code FFL 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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