EndoCore
FDA 510(k) clearance K230778 · decided 2023-09-25
Clearance details
- K-number
- K230778
- Device name
- EndoCore
- Applicant
- Praxis Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-03-21
- Decision date
- 2023-09-25
- Days to decision
- 188 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
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.