Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ToxiSeal™ Vial Adaptor with External Flip Balloon

K-Number: K241476 · 2024-06-21

ApplicantEpic Medical Pte. , Ltd.
Decision Date2024-06-21
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ToxiSeal™ Vial Adaptor with External Flip Balloon is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2024-06-21 under approval number K241476. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ToxiSeal™ Vial Adaptor with External Flip Balloon?

ToxiSeal™ Vial Adaptor with External Flip Balloon is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K241476.

When was ToxiSeal™ Vial Adaptor with External Flip Balloon approved by the FDA?

ToxiSeal™ Vial Adaptor with External Flip Balloon received FDA 510(k) clearance on 2024-06-21, under approval number K241476.

What company makes ToxiSeal™ Vial Adaptor with External Flip Balloon?

ToxiSeal™ Vial Adaptor with External Flip Balloon is manufactured by Epic Medical Pte. , Ltd..

What is the FDA product code for ToxiSeal™ Vial Adaptor with External Flip Balloon?

The FDA product code for ToxiSeal™ Vial Adaptor with External Flip Balloon is ONB.

Related Clinical Trials

NCT02761889 Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer COMPLETED NCT04035642 Single-Dose Image-Guided Radiotherapy With Urethral Sparing and DIL Boost for Intermediate-Risk Prostate Cancer (PROSINT II) RECRUITING

Other Devices by Epic Medical Pte. , Ltd.

K151650SMARTez elastomeric infusion pump K192075ProSeal™ Closed System drug Transfer Device (CSTD) K201626Safety Subcutaneous Infusion Set K230343ProSeal™ Closed System Administration Set K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) K240517ProSeal™ Vented Universal Vial Adaptor

View all 21 devices →

Related Devices (Code: ONB)

K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical , Ltd. K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K181221BD PhaSeal Optima Closed System Transfer DeviceBecton, Dickinson and Company K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc. K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial AdaptorJ & J Solutions, Inc. D/B/A/ Corvida Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑