ebb Complete Tamponade System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150573 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 for obstetric and gynecologic applications. It functions as a balloon catheter system intended to control postpartum hemorrhage by occluding the uterine cavity, reducing blood loss during or after childbirth.
This system is supplied as a sterile, single-use device and is regulated under 21 CFR 884.4530, with FDA clearance via a 510(k) submission (K150573). It is classified as a Class II medical device and is intended for use in obstetrics/gynecology settings, adhering to standard sterile processing and storage protocols for intrauterine devices.
Frequently asked questions
What clinical scenarios is the ebb Complete Tamponade System intended to address in obstetrics and gynecology?
The ebb Complete Tamponade System is designed specifically to control postpartum hemorrhage by occluding the uterine cavity, helping to reduce blood loss during or after childbirth. It is not intended for general gynecologic use but focuses on obstetric applications where hemorrhage management is critical.
Is the ebb Complete Tamponade System reusable or single-use, and how should it be stored?
The ebb Complete Tamponade System is a sterile, single-use device, meaning it is intended for one-time use only. It must be stored according to standard sterile processing protocols for intrauterine devices to maintain its integrity and sterility until use.
What regulatory pathway was followed for FDA clearance of the ebb Complete Tamponade System, and what classification does it hold?
The ebb Complete Tamponade System received FDA clearance through a 510(k) submission (K150573) under the Obstetrics/Gynecology advisory committee, classified as a Class II medical device. The clearance was granted as substantially equivalent to a predicate device, following the Special clearance type.
Are there multiple sizes or models available for the ebb Complete Tamponade System, and how would a clinician determine the appropriate one?
The device data does not specify individual sizes or models, but the ebb Complete Tamponade System is designed as a balloon catheter system for intrauterine use. Selection would typically depend on clinical guidelines, patient anatomy, and the specific requirements of the procedure, though exact sizing details would need to be confirmed with the manufacturer.
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 | K150573 | Class II | Active |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
Sources (1)
- FDA 510(k) K150573 24 fields · synced Sep 18, 2026