FDA product code FFK: Lithotriptor, Electro-Hydraulic
FFK is the FDA product code for lithotriptor, electro-hydraulic. It is a Class II device, regulated under 21 CFR 876.4480 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 61 510(k) submissions under FFK, 3 in the last five years, from 26 different applicants. The average 510(k) review took 138 days (median 107); 177 days on average over the last three years. FDA has posted 21 recalls for FFK devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lithotriptor, Electro-Hydraulic |
| Device class | Class II |
| Regulation | 21 CFR 876.4480 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FFK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 30 |
| 2021 | 1 | 263 |
| 2023 | 1 | 189 |
| 2025 | 2 | 177 |
Compare with all 510(k) review times · Search every FFK clearance
Top FFK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Northgate Technologies, Inc. | 11 | 2021-06-14 |
| Cybersonics, Inc. | 5 | 2013-11-26 |
| Northgate Research, Inc. | 5 | 1990-11-16 |
| Richard Wolf Medical Instruments Corp. | 4 | 2001-09-17 |
| Electro Medical Systems SA | 4 | 2001-08-24 |
21 more applicants have FFK clearances. See the full list in Caduvo.
Most recent FFK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242888 | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Electrohydraulic Lithotriptor (TCS-B3-II) | 2025-03-21 | 179 |
| K243032 | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | 2025-03-21 | 175 |
| K230488 | Walz Elektronik GmbH | EL27-Compact; Sterile EHL-Probes | 2023-08-31 | 189 |
| K202813 | Northgate Technologies, Inc. | URO-TOUCH 9 French Probe | 2021-06-14 | 263 |
| K191124 | E.M.S Electro Medical Systems S.A | Swiss LithoClast Trilogy | 2019-05-29 | 30 |
Recalls for FFK devices
21 product recalls in 10 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2022-04-13.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 7 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code FFK?
FFK is the FDA product code for lithotriptor, electro-hydraulic. It is a Class II device, regulated under 21 CFR 876.4480 and reviewed by the Gastroenterology and Urology panel.
What device class is FFK?
Class II, regulation 21 CFR 876.4480. Typical premarket route: 510(k).
How long does a 510(k) take for product code FFK?
Across 61 cleared submissions the average was 138 days from receipt to decision (median 107).
Which companies have the most FFK clearances?
Northgate Technologies, Inc. (11); Cybersonics, Inc. (5); Northgate Research, Inc. (5); Richard Wolf Medical Instruments Corp. (4); Electro Medical Systems SA (4).
Have FFK devices been recalled?
Yes: 21 product recalls across 10 recall events; the most recent began 2022-04-13.
Next steps
- Run an FDA pathway report with predicate devices for product code FFK
- Run a recall and safety report across every FFK manufacturer
- Watch product code FFK 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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