Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
FDA 510(k) clearance K173626 · decided 2018-02-21
Clearance details
- K-number
- K173626
- Device name
- Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-11-24
- Decision date
- 2018-02-21
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- 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
| Record | Firm | Date |
|---|---|---|
| a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Le recall (Z-1793-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-09-26 |