ViziShot 2 FLEX
FDA 510(k) clearance K193517 · decided 2020-03-18
Clearance details
- K-number
- K193517
- Device name
- ViziShot 2 FLEX
- Applicant
- Olympus Surgical Technologies America
- Decision
- Substantially Equivalent
- Date received
- 2019-12-19
- Decision date
- 2020-03-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KTI
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 recall (Z-2484-2025) | Olympus Corporation of the Americas | 2025-09-05 |