EXPECT ENDOSCOPIC ASPIRATION NEEDLE
FDA 510(k) clearance K110030 · decided 2011-01-12
Clearance details
- K-number
- K110030
- Device name
- EXPECT ENDOSCOPIC ASPIRATION NEEDLE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2011-01-05
- Decision date
- 2011-01-12
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- ODG
- Device class
- 2
- Regulation number
- 876.1500
- 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 |