Submission Details
| 510(k) Number | K223914 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 2022 |
| Decision Date | April 05, 2024 |
| Days to Decision | 463 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
ACTIV? Cap
Apr 2024
Decision
463d
Days
Class 2
Risk
About This 510(k) Submission
K223914 is an FDA 510(k) clearance for the ACTIV? Cap, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by Cleansite Medical, Inc. (Solana Beach, US). The FDA issued a Cleared decision on April 5, 2024, 463 days after receiving the submission on December 29, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | QBP — Cap, Device Disinfectant |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| Definition | Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time |
Manufacturer
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