FDA product code FCG: Biopsy Needle
FCG is the FDA product code for biopsy needle. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 133 510(k) submissions under FCG, 9 in the last five years, from 80 different applicants. The average 510(k) review took 115 days (median 82); 96 days on average over the last three years. FDA has posted 54 recalls for FCG devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Biopsy Needle |
| Device class | Class II |
| Regulation | 21 CFR 876.1075 |
| 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 FCG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 224 |
| 2018 | 6 | 166 |
| 2020 | 1 | 240 |
| 2021 | 1 | 90 |
| 2022 | 2 | 306 |
| 2023 | 4 | 206 |
| 2024 | 1 | 90 |
| 2025 | 2 | 103 |
Compare with all 510(k) review times · Search every FCG clearance
Top FCG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Ireland, Ltd. | 7 | 2024-07-29 |
| Olympus Medical Systems Corp. | 6 | 2025-10-24 |
| Wilson-Cook Medical, Inc. | 5 | 2017-08-04 |
| H.S. Hospital Services S.P.A. | 4 | 2014-10-10 |
| Medi-Globe Corporation | 4 | 2014-05-15 |
75 more applicants have FCG clearances. See the full list in Caduvo.
Most recent FCG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252646 | Olympus Medical Systems Corp. | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | 2025-10-24 | 64 |
| K250994 | Finemedix Co., Ltd. | ClearTip FNA and FNB Types | 2025-08-21 | 142 |
| K241209 | Cook Ireland, Ltd. | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | 2024-07-29 | 90 |
| K231422 | Limaca Medical, Ltd. | Precision GI | 2023-08-28 | 103 |
| K231267 | Finemedix Co., Ltd. | ClearTip | 2023-06-30 | 59 |
Recalls for FCG devices
54 product recalls in 20 recall events; 7 initiated in the last five years and 9 still open. Most recent: 2024-08-02.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2020 | 2 |
| 2021 | 5 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 4 |
Frequently asked questions
What is FDA product code FCG?
FCG is the FDA product code for biopsy needle. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.
What device class is FCG?
Class II, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
How long does a 510(k) take for product code FCG?
Across 133 cleared submissions the average was 115 days from receipt to decision (median 82).
Which companies have the most FCG clearances?
Cook Ireland, Ltd. (7); Olympus Medical Systems Corp. (6); Wilson-Cook Medical, Inc. (5); H.S. Hospital Services S.P.A. (4); Medi-Globe Corporation (4).
Have FCG devices been recalled?
Yes: 54 product recalls across 20 recall events; the most recent began 2024-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code FCG
- Run a recall and safety report across every FCG manufacturer
- Watch product code FCG 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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