FemVue MINI Saline-Air Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Femasys Inc.
Identifiers
- 510(k) Number
- K242002 FDA 510(k)
- FDA Product Code
- LKF 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 FemVue MINI Saline-Air Device is a uterine cannula and manipulator designed for hysterosalpingography (HSG) procedures. It delivers a continuous, alternating stream of saline and air as a contrast medium to visualize the fallopian tubes and uterine cavity during imaging.
This device is intended for single-use in clinical settings and is classified as a Class II medical device under FDA regulations. It is supplied sterile and requires no additional preparation beyond standard aseptic techniques. The device is authorized under FDA 510(k) clearance (K242002) and meets MDR requirements, with registration numbers including 1825146 and others listed under the specified regulation (884.4530).
Frequently asked questions
What is the primary purpose of the FemVue MINI Saline-Air Device in clinical procedures?
The FemVue MINI Saline-Air Device is specifically designed for hysterosalpingography (HSG) procedures, where it delivers a continuous, alternating stream of saline and air as a contrast medium. This allows radiologists to visualize the fallopian tubes and uterine cavity during imaging, helping to diagnose conditions like tubal blockages or uterine abnormalities.
Is the FemVue MINI Saline-Air Device intended for single-use or reusable applications?
The device is explicitly intended for single-use only in clinical settings. It is supplied sterile and does not require additional preparation beyond standard aseptic techniques, ensuring patient safety and compliance with infection control protocols.
How is the regulatory authorization for this device structured, and what does it signify?
The FemVue MINI Saline-Air Device holds FDA 510(k) clearance (K242002) under the Traditional 510(k) review pathway, with a decision code of SESE (Substantially Equivalent). This means the device is deemed comparable to a legally marketed predicate in terms of technology and safety. It also complies with EU MDR (Medical Device Regulation) requirements, as indicated by the registration numbers listed under regulation 884.4530.
What special handling or storage instructions should be followed for the FemVue MINI Saline-Air Device?
Since the device is sterile and single-use, it should be stored in its original packaging until use to maintain sterility. No additional preparation is required beyond adhering to standard aseptic techniques during the procedure. Always check the expiration date and ensure the packaging remains intact before use.
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: Fallopian Tube Test | FemVue, FemVue® - Sono HSG – obgyn.ivfstore.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242002 | Class II | Active |
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Manufacturer
- Manufacturer
- Femasys Inc.
- FDA Applicant
- Femasys, Inc.
Sources (2)
- FDA 510(k) K242002 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026