K221513 is an FDA 510(k) clearance for the Equashield Closed System Transfer Device. This device is classified as a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II - Special Controls, product code ONB).
Submitted by Equashield Medical , Ltd. (Migdal Tefen, IL). The FDA issued a Cleared decision on February 17, 2023, 268 days after receiving the submission on May 25, 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 | K221513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2022 |
| Decision Date | February 17, 2023 |
| Days to Decision | 268 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. |