510(k) K222929
K222929 is an FDA 510(k) premarket notification submitted by Epic Medical Pte. , Ltd. for the device "ToxiSeal Vial Adapter with External Balloon". The FDA issued a decision of Substantially Equivalent on January 11, 2024. The device falls under product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System), a Class II device regulated under 21 CFR 880.5440. Epic Medical Pte. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2024
- Date Received
- September 26, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.