K240171 is an FDA 510(k) clearance for the ProSeal™ Injector Plus (Model no. 421050). This device is classified as a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II - Special Controls, product code ONB).
Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on March 28, 2024, 66 days after receiving the submission on January 22, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440. Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting..
| 510(k) Number | K240171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2024 |
| Decision Date | March 28, 2024 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| Definition | Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting. |