CORIOGRAPH Pre-Op Planning and Modeling Services
FDA 510(k) clearance K242272 · decided 2024-11-15
Clearance details
- K-number
- K242272
- Device name
- CORIOGRAPH Pre-Op Planning and Modeling Services
- Applicant
- Blue Belt Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-01
- Decision date
- 2024-11-15
- Days to decision
- 106 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.