SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
FDA 510(k) clearance K251666 · decided 2026-04-08
Clearance details
- K-number
- K251666
- Device name
- SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-05-30
- Decision date
- 2026-04-08
- Days to decision
- 313 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- 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.