Prolystica Pass Thru Disinfectant Wipes
FDA 510(k) clearance DEN240075 · decided 2026-05-01
Clearance details
- K-number
- DEN240075
- Device name
- Prolystica Pass Thru Disinfectant Wipes
- Applicant
- Steris
- Decision
- Unknown
- Date received
- 2024-12-12
- Decision date
- 2026-05-01
- Days to decision
- 505 days
- Clearance type
- Direct
- Product code
- SHM
- Device class
- 2
- Regulation number
- 880.6891
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.