RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
FDA 510(k) clearance K100712 · decided 2010-03-30
Clearance details
- K-number
- K100712
- Device name
- RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-03-12
- Decision date
- 2010-03-30
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Us recall (Z-3215-2011) | Boston Scientific Corporation | 2011-09-16 |
| Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72 recall (Z-0809-2011) | Boston Scientific Corporation | 2010-12-27 |
| Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52 recall (Z-0810-2011) | Boston Scientific Corporation | 2010-12-27 |
| Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, recall (Z-0811-2011) | Boston Scientific Corporation | 2010-12-27 |
| Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, recall (Z-0812-2011) | Boston Scientific Corporation | 2010-12-27 |
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