Submission Details
| 510(k) Number | K243475 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 08, 2024 |
| Decision Date | December 04, 2024 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
Chemical Indicator for enspire CLCSPS (LCC015)
Dec 2024
Decision
26d
Days
Class 2
Risk
About This 510(k) Submission
K243475 is an FDA 510(k) clearance for the Chemical Indicator for enspire CLCSPS (LCC015), a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on December 4, 2024, 26 days after receiving the submission on November 8, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
Manufacturer
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