Cervex-Brush, Cervical Spatula, Cytology, Sterile
510(k) K942843
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942843 | Date8 Dec 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Cervex-Brush(R), Sterile, Spatula, Cervical, Cytology
- 510(k) Number
- FDA Product Code
- HHT
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Cervex-Brush is a cervical spatula designed for cytology sampling, classified as a Spatula, Cervical, Cytological device. It is intended for collecting cellular samples from the cervix to aid in the detection of abnormalities, including cervical cancer precursors. The device is engineered to provide a reliable and efficient method for obtaining high-quality smears during gynecological examinations.
This single-use, sterile device is supplied for use in clinical settings, including obstetrics and gynecology. It is regulated under FDA 510(k) clearance (K942843) and falls under device class II. The Cervex-Brush is not MRI-compatible and must be handled in accordance with standard sterile instrument protocols. No additional regulatory markings beyond the stated clearance are provided in the specifications.
Other devices from Rovers Diagnostic Devices
Questions
AI-generated answers, 19 Sep 2026
What is the primary clinical use of the Cervex-Brush® in gynecological examinations?
The Cervex-Brush® is specifically designed for collecting cellular samples from the cervix during gynecological exams. Its purpose is to aid in detecting abnormalities, such as cervical cancer precursors, by providing high-quality cytology smears for laboratory analysis. This makes it a critical tool in preventive screening and diagnostic procedures.
Is the Cervex-Brush® intended for reuse, or is it meant to be used only once per patient?
The Cervex-Brush® is explicitly labeled as a single-use device. This ensures sterility and safety for each patient, aligning with standard sterile instrument protocols in clinical settings like obstetrics and gynecology. Reuse is not recommended or supported by the manufacturer.
How should the Cervex-Brush® be stored to maintain its integrity before use?
While the packaging details are not specified, the device is sterile and intended for clinical use. It should be stored in a clean, dry environment, protected from contamination, and kept within the manufacturer’s recommended shelf life. Always follow the included instructions for storage to preserve sterility and functionality.
Are there different sizes or models of the Cervex-Brush® available, or is it a single standardized design?
The provided data lists multiple registration numbers and FEI numbers, which typically correspond to variations in design, size, or packaging (e.g., different lot sizes or packaging configurations). However, the core device remains a cervical cytology spatula with no explicit size variations mentioned in the description. For exact sizing or model-specific details, refer to the manufacturer’s packaging or technical documentation.
Can the Cervex-Brush® be used in conjunction with MRI procedures, or are there any compatibility concerns?
The Cervex-Brush® is not MRI-compatible, as explicitly stated in the specifications. This means it should not be used in or near MRI environments, as the device could interfere with imaging or pose risks during the procedure. Always verify compatibility with imaging equipment before use.