Fowler Endocurette, Model CUR-XXX
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EndoCurette EUDAMEDFDA UDI
- Generic Name
- Endometrial biopsy curette FDA UDI
- Device Name
- Endocurette EUDAMEDEndometrial Suction Curette FDA UDI
- Model / Reference
- CUR-100 EUDAMED100 FDA UDI
- Description
- Endometrial Suction Curette FDA UDI
Identifiers
- Catalog Number
- CUR-100 FDA UDI
- Primary DI / UDI-DI
- H671CUR1000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++H671CE027IIADJ EUDAMED
- 510(k) Number
- FDA Product Code
- HHK FDA 510(k)FDA UDI
- EMDN Code
- U080101 CATHETERS FOR ENDOMETRIAL ABLATION EUDAMED
- GMDN Term
- Endometrial biopsy curette FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 884.1175 FDA 510(k)
- Regulation Number
- 884.1175 FDA 510(k)FDA UDI
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Yes
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
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 27 Centimeter FDA UDIOuter Diameter — 3.1 Millimeter FDA UDI
The Fowler Endocurette, Model CUR-XXX, is a Curette, Suction, Endometrial (and Accessories) designed for endometrial sampling. This device combines suction and curettage techniques to collect tissue from the uterine lining, aiding in diagnostic procedures for conditions such as abnormal uterine bleeding or suspected endometrial pathology. Its dual-action mechanism enhances precision and efficiency in obtaining representative samples for histopathological examination.
The Fowler Endocurette is intended for use in clinical settings by trained healthcare professionals, typically in obstetrics and gynecology. Supplied as a reusable device, it requires proper sterilization between uses to maintain safety and efficacy. The device adheres to FDA 510(k) and MDR regulatory standards, ensuring compliance with medical device requirements. Model-specific variations are identified by the exact reference code CUR-XXX, with no additional modifications or accessories specified beyond those inherent to its design.
Frequently asked questions
Is the Fowler Endocurette, Model CUR-XXX designed for single-use or reusable applications, and what sterilization requirements apply?
The Fowler Endocurette, Model CUR-XXX is explicitly designed as a reusable device, requiring proper sterilization between uses to ensure safety and effectiveness. Since it is intended for endometrial sampling in clinical settings, adherence to strict sterilization protocols—such as autoclaving or chemical sterilization—is essential to prevent cross-contamination and maintain regulatory compliance.
What clinical specialties or settings is the Fowler Endocurette primarily intended for, and why?
The device is primarily intended for use in obstetrics and gynecology settings, as indicated by its classification under the Obstetrics/Gynecology advisory committee and product code (HHK). Its dual-action suction and curettage mechanism is specifically engineered to assist in diagnostic procedures like endometrial sampling for conditions such as abnormal uterine bleeding or suspected endometrial pathology, making it a specialized tool for these specialties.
How do I identify the correct model of the Fowler Endocurette, and are there variations beyond the CUR-XXX designation?
The exact model is identified by the reference code CUR-XXX, with no additional modifications or accessories specified beyond those inherent to its design. While the data does not list specific size variations, the model-specific designation (CUR-XXX) ensures traceability and compliance with regulatory submissions. Always verify the exact CUR-XXX code on the device packaging or labeling to confirm the correct model.
What regulatory pathways does the Fowler Endocurette follow, and how does this affect its use or distribution?
The device follows FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming it meets U.S. and EU regulatory standards for safety and performance. This means it has undergone evaluation by the FDA’s Obstetrics/Gynecology advisory committee and is classified as Class II, requiring adherence to manufacturing, labeling, and post-market surveillance requirements. These pathways ensure its suitability for clinical use in endometrial sampling procedures.
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 | K000974 | Class II | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (3)
- FDA 510(k) K000974 24 fields · synced Oct 6, 2026
- FDA UDI 7d6908bc-21d1-4cd6-9787-e13024fa8cec 37 fields · synced May 30, 2026
- EUDAMED 5191fc78-c24c-4a25-83b9-e36e87e08df7 61 fields · synced Jul 8, 2026