510(k) K241209
- Device
- EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
- Applicant
- Cook Ireland, Ltd.
- 510(k) number
- K241209
- Product code
- FCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-29
- Date received
- 2024-04-30
- Regulation
- 876.1075
- Classification name
- Biopsy Needle
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Brian O'Mara
- Address
- O' Halloran Rd., National Technology Park, Plassey Limerick IE V94 N8X2 V94 N8X2
FDA Registration Numbers
- 3006788678
- 3007544634
- 1825146
- 3030125051
- 3038356900
- 1423507
- 3014769442
- 9617592
- 1061124
- 3004129994
- 3012334073
- 2183744
- 3012536737
- 3043585886
- 3001845648
- 3027641465
- 3005012805
- 3030447506
- 3011050570
- 3013557562
- 2246552
- 2133772
- 3012936513
- 1225687
- 1721676
- 3007664053
- 3010515547
- 1820334
- 3033589330
- 3006950086
- 3005099803
- 3004749705
- 3017210488
- 3002807314
- 3008773560
- 9611612
- 1018233
- 1417485
- 1828132
- 3030733800
- 3004904811
- 1037905
- 1625425
- 3030626857
- 2518897
- 1835568
- 3029779285
- 3014279513
- 9680809
- 1058584
- 3011146996
- 3008040402
- 3009526575
- 3012975098
- 3042940295
- 9617616
- 3014579161
- 1928237
- 1000393132
- 1724474
- 3010966701
- 1319639
- 3010188783
- 3008044552
- 3004784537
- 9614641
- 3011088743
- 3000126629
- 2030624
- 3030446844
- 3013440400
- 3012494290
- 9615480
- 3005580113
- 3015924373
- 3015077548
- 1211566
- 3006849754
- 1000112137
Source Documents
Other 510(k) Records For Product Code FCG
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | 2025-10-24 |
| K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | 2025-08-21 |
| K231422 | Precision GI | Limaca Medical, Ltd. | 2023-08-28 |
| K231267 | ClearTip | Finemedix Co., Ltd. | 2023-06-30 |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023-05-30 |
| K212423 | EndoDrill® Model X | Bibbinstruments AB | 2023-03-29 |
| K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| 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. | 2021-05-20 |
| K191472 | Biopsy Needle | Ushare Medical, Inc. | 2020-01-29 |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | Apriomed AB | 2018-12-18 |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. | 2018-11-15 |
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | 2018-11-01 |
| K181994 | Single Use Aspiration Needle NA-U201H | Olympus Medical Systems Corp. | 2018-10-31 |
| K180449 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | 2018-06-08 |