FCG · Biopsy Needle
Gastroenterology, Urology · 21 CFR 876.1075 · Class 2
Overview
| Product Code | FCG |
|---|---|
| Device Name | Biopsy Needle |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 133)
Showing 20 most recent of 133 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | Oct 24, 2025 | SESE |
| K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | Aug 21, 2025 | SESE |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. | Jul 29, 2024 | SESE |
| K231422 | Precision GI | Limaca Medical, Ltd. | Aug 28, 2023 | SESE |
| K231267 | ClearTip | Finemedix Co., Ltd. | Jun 30, 2023 | SESE |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | May 30, 2023 | SESE |
| K212423 | EndoDrill® Model X | Bibbinstruments AB | Mar 29, 2023 | SESE |
| K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | Jul 6, 2022 | SESE |
| K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | Jul 6, 2022 | SESE |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle | Cook Ireland, Ltd. | May 20, 2021 | SESE |
| K191472 | Biopsy Needle | Ushare Medical, Inc. | Jan 29, 2020 | SESE |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | Apriomed AB | Dec 18, 2018 | SESE |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. | Nov 15, 2018 | SESE |
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | Nov 1, 2018 | SESE |
| K181994 | Single Use Aspiration Needle NA-U201H | Olympus Medical Systems Corp. | Oct 31, 2018 | SESE |
| K180449 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | Jun 8, 2018 | SESE |
| K180037 | Beacon EUS Access System | Covidien, LLC | Apr 26, 2018 | SESE |
| K171956 | Sterile Endoscope Biopsy Sampling Needle | Changzhou Detain Medical Devices Co., Ltd. | Dec 12, 2017 | SESE |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle | Wilson-Cook Medical, Inc. | Aug 4, 2017 | SESE |
| K160890 | Howell Biliary Introducer Needle | Wilson-Cook Medical, Inc. | Jun 14, 2017 | SESE |
Top Applicants
- Cook Ireland, Ltd. — 7 clearances
- Olympus Medical Systems Corp. — 6 clearances
- Wilson-Cook Medical, Inc. — 5 clearances
- Promex, Inc. — 4 clearances
- Medi-Globe Corporation — 4 clearances
