ebb Complete Tamponade System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153591 FDA 510(k)
- FDA Product Code
- OQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ebb Complete Tamponade System is an Intrauterine Tamponade Balloon, designed to control postpartum hemorrhage by occluding the uterine cavity. It consists of a balloon catheter system that, when inflated, applies pressure to the uterine walls to reduce bleeding during or after childbirth.
This system is supplied as a sterile, single-use device intended for use in obstetrics/gynecology settings. It is regulated under 21 CFR 884.4530, classified as a Class II medical device, and has received FDA 510(k) clearance (K153591). The device is packaged for one-time use and must be handled under aseptic conditions prior to deployment.
Frequently asked questions
What is the primary clinical purpose of the ebb Complete Tamponade System and how does it work?
The ebb Complete Tamponade System is designed to control postpartum hemorrhage by occluding the uterine cavity. It works by inflating an intrauterine balloon catheter, which applies pressure to the uterine walls to reduce bleeding during or after childbirth. This is particularly useful in obstetrics/gynecology settings where hemorrhage management is critical.
Is the ebb Complete Tamponade System intended for single-use or can it be reused?
The ebb Complete Tamponade System is explicitly supplied as a sterile, single-use device. It must be handled under aseptic conditions prior to deployment and is not intended for reuse, ensuring patient safety and infection control.
How should the ebb Complete Tamponade System be stored before use?
Since the device is sterile and single-use, it must be stored in its original packaging until ready for use. The packaging is designed to maintain sterility, so it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity.
What regulatory pathway was followed for the ebb Complete Tamponade System, and what classification does it hold?
The ebb Complete Tamponade System was cleared through the FDA’s 510(k) pathway (K153591) and is classified as a Class II medical device under 21 CFR 884.4530. This classification reflects its intended use in controlling postpartum hemorrhage, with oversight by the Obstetrics/Gynecology advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ebb Complete Tamponade System (K153591) — FDA 510(k) | Innolitics, ebb Complete Tamponade System (K150573) — FDA 510(k) | Innolitics, Ebb Complete Tamponade System 510(k) K153591 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153591 | Class II | Active |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
Sources (1)
- FDA 510(k) K153591 24 fields · synced Sep 18, 2026