PeriView FLEX
FDA 510(k) clearance K171232 · decided 2017-09-21
Clearance details
- K-number
- K171232
- Device name
- PeriView FLEX
- Applicant
- Olympus Surgical Technologies America
- Decision
- Substantially Equivalent
- Date received
- 2017-04-27
- Decision date
- 2017-09-21
- Days to decision
- 147 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
No recalls on record reference this clearance.