FCG — Biopsy Needle Class II
FDA Device Classification
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 |