FCG — Biopsy Needle Class II
FDA product code FCG covers "Biopsy Needle", a Class II medical device regulated under 21 CFR 876.1075. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCG
- Device Class
- Class II
- Regulation Number
- 876.1075
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252646 | olympus medical systems | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | October 24, 2025 |
| K250994 | finemedix co | ClearTip FNA and FNB Types | August 21, 2025 |
| K241209 | cook ireland | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | July 29, 2024 |
| K231422 | limaca medical | Precision GI | August 28, 2023 |
| K231267 | finemedix co | ClearTip | June 30, 2023 |
| K230909 | cook ireland | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) | May 30, 2023 |
| K212423 | bibbinstruments | EndoDrill® Model X | March 29, 2023 |
| K212822 | suzhou leapmed healthcare corporation | Disposable Coaxial Biopsy Needle | July 6, 2022 |
| K212819 | suzhou leapmed healthcare corporation | Disposable Biopsy Refill Needle | July 6, 2022 |
| K210476 | cook ireland | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy | May 20, 2021 |
| K191472 | ushare medical | Biopsy Needle | January 29, 2020 |
| K181756 | apriomed | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | December 18, 2018 |
| K180668 | olympus medical systems | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | November 15, 2018 |
| K180363 | finemedix co | Clear-Tip EUS-FNA | November 1, 2018 |
| K181994 | olympus medical systems | Single Use Aspiration Needle NA-U201H | October 31, 2018 |
| K180449 | olympus medical systems | Single Use Aspiration Needle NA-U200H | June 8, 2018 |
| K180037 | covidien | Beacon EUS Access System | April 26, 2018 |
| K171956 | changzhou detain medical devices co | Sterile Endoscope Biopsy Sampling Needle | December 12, 2017 |
| K171596 | wilson-cook medical | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle | August 4, 2017 |
| K160890 | wilson-cook medical | Howell Biliary Introducer Needle | June 14, 2017 |