Ellavi UBT Intrauterine Tamponade Balloon
by Sinapi Biomedical (Pty), Ltd. South Africa EUDAMED510(k)
510(k) K230849
Product code OQY
Overview
The Ellavi UBT is an Intrauterine Tamponade Balloon, a Class II medical device designed to control postpartum haemorrhage by occluding the uterine cavity. It is inserted via the cervix and inflated to apply pressure, reducing blood loss during childbirth or after delivery. The device is intended for use in obstetric settings where haemorrhage management is critical.
The Ellavi UBT is supplied as a single-use, sterile device and must be handled under aseptic conditions. It is compatible with MRI environments and comes in a pre-packaged, ready-to-use format for immediate clinical application. Authorised under FDA 510(k) clearance and MDR compliance, it adheres to regulatory standards for obstetrics/gynecology interventions. Storage requires protection from contamination and extreme temperatures, as specified in the manufacturer’s instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK230849 | Date13 Nov 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- Full name
- Ellavi Ubt
- 510(k) Number
- FDA Product Code
- OQY
- FDA applicant
- Sinapi Biomedical (Pty) , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Sinapi Biomedical (Pty), Ltd.
Questions
What is the primary clinical purpose of the Ellavi UBT in obstetric settings?
The Ellavi UBT is designed specifically to control postpartum haemorrhage by occluding the uterine cavity. It is inserted through the cervix and inflated to apply pressure, which helps reduce excessive blood loss during or immediately after childbirth in critical obstetric scenarios.
Is the Ellavi UBT intended for reuse, or is it meant to be used only once?
The Ellavi UBT is explicitly supplied as a single-use device. It must be handled under sterile conditions and discarded after one use to maintain patient safety and prevent contamination.
How should the Ellavi UBT be stored to ensure its integrity and usability?
The device requires storage in its original packaging to protect it from contamination and extreme temperatures. The manufacturer’s instructions should be followed closely, as improper storage could compromise sterility or functionality.
Can the Ellavi UBT be used in an MRI environment, and why does this matter?
Yes, the Ellavi UBT is compatible with MRI environments, which is important for facilities where imaging may be required during or after its use. This ensures clinicians can monitor the patient without removing the device.
What regulatory pathways does the Ellavi UBT follow, and how does this affect its use?
The Ellavi UBT is authorized under both FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for obstetrics/gynecology interventions. This ensures it adheres to safety and performance requirements for use in clinical settings.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K230849
- EUDAMED