510(k) K151895
- Device
- Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
- Applicant
- BOSTON SCIENTIFIC CORPORATION
- 510(k) number
- K151895
- Product code
- FCG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-22
- Date received
- 2015-07-10
- 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
- YINGYING GAO
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 9611481
- 3008773560
- 2528981
- 3016844398
- 1211566
- 3011146996
- 3011642792
- 3010966701
- 3011088743
- 2133772
- 2183456
- 3002807314
- 1625425
- 3012975098
- 1000121056
- 3043585886
- 8010047
- 3006788678
- 3011050570
- 1625685
- 1047843
- 3018094310
- 3027641465
- 3004784537
- 3009196578
- 1048735
- 1319639
- 1018233
- 1835568
- 1928237
- 3015924373
- 3004749705
- 3015136750
- 3007699067
- 9680904
- 1423507
- 1225687
- 3005216725
- 3029779285
- 9680269
- 1721686
- 1220477
- 1923569
- 3004837686
- 3005580113
- 3010273872
- 3003790304
- 3010515547
- 2124215
- 9617616
- 2020394
- 3010419931
- 3004111573
- 3004129994
- 9617592
- 1825146
- 3012936513
- 1037905
- 2134812
- 3015972753
- 3009337401
- 9680809
- 1820334
- 3030626857
- 1417485
- 3007664053
- 1061124
- 3005012805
- 1222140
- 3014769442
- 2518897
- 3038356900
- 3016678045
- 1828132
- 3015077548
- 3007544634
- 3030733800
- 1320894
- 2246552
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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