K222929 is an FDA 510(k) clearance for the ToxiSeal Vial Adapter with External Balloon. 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 January 11, 2024, 472 days after receiving the submission on September 26, 2022.
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 | K222929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | January 11, 2024 |
| Days to Decision | 472 days |
| Submission Type | Traditional |
| 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. |