Single Use Aspiration Needle NA-U401SX
FDA 510(k) clearance K160098 · decided 2016-03-22
Clearance details
- K-number
- K160098
- Device name
- Single Use Aspiration Needle NA-U401SX
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2016-01-19
- Decision date
- 2016-03-22
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ul recall (Z-1615-2023) | Olympus Corporation of the Americas | 2023-05-19 |
| To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) o recall (Z-1616-2023) | Olympus Corporation of the Americas | 2023-05-19 |