SteroScope® Sterilization Technology System
FDA 510(k) clearance K233762 · decided 2024-06-27
Clearance details
- K-number
- K233762
- Device name
- SteroScope® Sterilization Technology System
- Applicant
- Ideate Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-24
- Decision date
- 2024-06-27
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- MLR
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.