PAL Sterilization Case
FDA 510(k) clearance K243589 · decided 2025-06-20
Clearance details
- K-number
- K243589
- Device name
- PAL Sterilization Case
- Applicant
- Microaire Surgical Instruments, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-11-20
- Decision date
- 2025-06-20
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Charlottesville, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.