Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
FDA 510(k) clearance K163058 · decided 2017-01-30
Clearance details
- K-number
- K163058
- Device name
- Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2016-11-01
- Decision date
- 2017-01-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- 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
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.