Universal Endometrial Applicator Set GM11009840
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Universal Endometrial Applicator Set EUDAMEDFDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Universal Endometrial Applicator Set EUDAMED
- Model / Reference
- GM11009840 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11009840 FDA UDI
- Primary DI / UDI-DI
- 00810563022100 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201061PW EUDAMED
- FDA Product Code
- JAQ FDA 510(k)FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Universal Endometrial Applicator Set is a remote-controlled radionuclide applicator system designed for precise delivery of radiation in radiology procedures. It is classified as a Class II medical device and falls under the regulatory category for radionuclide applicators, enabling targeted therapeutic interventions in endometrial applications.
This set is intended for use in radiology settings and is supplied as a reusable device with FDA 510(k) clearance and MDR compliance. It is not MRI-safe and requires proper handling and storage as specified by the manufacturer. The system includes multiple applicator references for various clinical applications, adhering to regulatory standards outlined in 21 CFR 892.5700.
Frequently asked questions
What clinical specialties is this device designed for and how does it differ from standard radionuclide applicators?
The Universal Endometrial Applicator Set is specifically designed for use in radiology settings, particularly for targeted radiation therapy in endometrial applications. Unlike general radionuclide applicators, it is engineered for remote-controlled precision delivery, ensuring accurate placement during procedures. The system adheres to 21 CFR 892.5700 standards and includes multiple applicator references tailored for endometrial interventions, distinguishing it from broader applicator systems.
Is this device reusable, and if so, what maintenance or handling considerations should be noted?
Yes, the Universal Endometrial Applicator Set is reusable, as explicitly stated in the manufacturer’s specifications. Since it is not sterile out-of-the-box, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality. The device requires careful handling and storage as outlined by Varian Medical Systems, Inc., and should not be used in MRI environments due to its non-MRI-safe designation.
What regulatory pathways does this device follow, and how does that impact its use in clinical settings?
The device has received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent), and complies with MDR (Medical Device Regulation) standards. This means it has been evaluated for safety and effectiveness against a predicate device and meets regulatory requirements for Class II radionuclide applicators. Clinicians can rely on its compliance with these pathways for radiation therapy procedures, ensuring adherence to established safety and performance benchmarks.
Are there multiple sizes or models available, and how does this affect its versatility in treatment?
The device includes multiple applicator references, as indicated by the extensive list of FEI numbers (e.g., 1000523114, 3000270450, etc.), suggesting a range of sizes or configurations. This modularity allows clinicians to select the appropriate applicator for specific endometrial applications, enhancing versatility in treatment planning and precision during procedures. The exact sizes or models would be detailed in the manufacturer’s documentation.
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.
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 | K232623 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (3)
- FDA 510(k) K232623 24 fields · synced Oct 6, 2026
- FDA UDI c15a1531-ce89-4a03-81ec-550af4b9e858 34 fields · synced May 30, 2026
- EUDAMED 22fc6733-b77c-4f6d-af42-7570170b1f80 61 fields · synced Jul 18, 2026