FDA product code FAS: Electrode, Electrosurgical, Active, Urological
FAS is the FDA product code for electrode, electrosurgical, active, urological. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 58 510(k) submissions under FAS, 4 in the last five years, from 34 different applicants. The average 510(k) review took 140 days (median 116); 141 days on average over the last three years. FDA has posted 9 recalls for FAS devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Electrosurgical, Active, Urological |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| 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 FAS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 145 |
| 2021 | 2 | 125 |
| 2022 | 1 | 156 |
| 2024 | 1 | 112 |
| 2025 | 2 | 170 |
Compare with all 510(k) review times · Search every FAS clearance
Top FAS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Winter & Ibe GmbH | 6 | 2021-08-03 |
| Arthrocare Corp. | 5 | 2003-06-19 |
| Omnitech Systems, Inc. | 4 | 2016-06-27 |
| Greenwald Surgical Co., Inc. | 3 | 1994-04-01 |
| Chirurgie Innovation | 2 | 2022-03-02 |
29 more applicants have FAS clearances. See the full list in Caduvo.
Most recent FAS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251403 | Dornier Medtech America Inc (Dmta) | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | 2025-12-05 | 213 |
| K250522 | Multi4 Medical AB | Multi4 System | 2025-06-27 | 126 |
| K240504 | Lamidey Noury Medical | PLASMA EDGE System | 2024-06-12 | 112 |
| K213135 | Chirurgie Innovation | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge | 2022-03-02 | 156 |
| K210651 | Olympus Winter & Ibe GmbH | Resection Electrodes with HF cable | 2021-08-03 | 152 |
Recalls for FAS devices
9 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-10-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 4 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code FAS?
FAS is the FDA product code for electrode, electrosurgical, active, urological. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is FAS?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code FAS?
Across 58 cleared submissions the average was 140 days from receipt to decision (median 116).
Which companies have the most FAS clearances?
Olympus Winter & Ibe GmbH (6); Arthrocare Corp. (5); Omnitech Systems, Inc. (4); Greenwald Surgical Co., Inc. (3); Chirurgie Innovation (2).
Have FAS devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2023-10-02.
Next steps
- Run an FDA pathway report with predicate devices for product code FAS
- Run a recall and safety report across every FAS manufacturer
- Watch product code FAS 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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