FCG
- Product code
- FCG
- Device name
- Biopsy Needle
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1075
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 133 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252646 | 2025-10-24 | Olympus Medical Systems Corp. | Single-Use Fine Needle Biopsy (FNB) device (NA-U210… | |
| K250994 | 2025-08-21 | Finemedix Co., Ltd. | ClearTip FNA and FNB Types | |
| K241209 | 2024-07-29 | Cook Ireland, Ltd. | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) |
Official FDA classification page: FCG
Classification and pathway per current FDA publications. Data from openFDA (CC0).