510(k) K210476
- Device
- 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
- Applicant
- Cook Ireland Ltd.
- 510(k) number
- K210476
- Product code
- FCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-20
- Date received
- 2021-02-19
- 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
- No
Applicant Contact#
- Contact
- Fay Dalton
- Address
- O' Halloran Rd. National Technology Park Limerick IE V94 N8X2 V94 N8X2
FDA Registration Numbers#
- 1825146
- 3030447506
- 3030626857
- 1018233
- 9680794
- 1835568
- 8010047
- 3004904811
- 3005580113
- 3012975098
- 1625425
- 1061124
- 3004837686
- 3000126629
- 3010041511
- 1923569
- 3010188783
- 3015924373
- 3012536737
- 3004111573
- 1000121056
- 2030624
- 1724474
- 3008040402
- 3033589330
- 9617616
- 3011146996
- 3016844398
- 1417485
- 9680809
- 2124215
- 2183744
- 3010966701
- 3009526575
- 3008773560
- 3042940295
- 3004129994
- 1221435
- 3013440400
- 1928237
- 3015309643
- 1222140
- 9680269
- 3012042439
- 1319639
- 3011050570
- 3010419931
- 2518897
- 3004784537
- 9611612
- 3016678045
- 3010273872
- 1820334
- 3029779285
- 1528319
- 3007664053
- 8010312
- 3014769442
- 3002806603
- 3003790304
- 3030733800
- 1000112137
- 3005012805
- 1423507
- 3001845648
- 2183456
- 1058584
- 1037905
- 3011642792
- 3013557562
- 3011137372
- 3005216725
- 3002807314
- 3009196578
- 3014579161
- 9614641
- 1225687
- 1625685
- 9611481
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 |
| K241209 | EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. | 2024-07-29 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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