ONE TRAY® Sealed Sterilization Container System
FDA 510(k) clearance K250029 · decided 2025-05-01
Clearance details
- K-number
- K250029
- Device name
- ONE TRAY® Sealed Sterilization Container System
- Applicant
- Innovative Sterilization Technologies
- Decision
- Substantially Equivalent
- Date received
- 2025-01-06
- Decision date
- 2025-05-01
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dayton, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.