SEILER COLPOSCOPE - 935
by Seiler Precision Microscopes
510(k) K101141
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101141 | Date6 Aug 2010 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- HEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1630
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Seiler Colposcope Models 935, 955, and 985 are optical diagnostic instruments classified as colposcopes and colpomicroscopes. These devices are designed for visual examination of the cervix, vagina, and vulva, enabling clinicians to identify abnormalities such as dysplasia, lesions, or cervical cancer precursors. Equipped with magnification and illumination systems, they facilitate precise inspection of tissue surfaces during gynecological evaluations. The models vary in features to accommodate different clinical workflows and diagnostic requirements.
These colposcopes are intended for use in obstetrics and gynecology settings, supplied as reusable medical devices. They are not sterile upon delivery and require cleaning and maintenance between uses. The models are categorized under FDA 510(k) clearance (K101141) as substantially equivalent to predicate devices, adhering to regulatory standards for Class II medical devices. Storage and handling follow manufacturer guidelines to ensure optimal performance and longevity, with no specific MRI safety classifications indicated.
Questions
AI-generated answers, 1 Oct 2026
What clinical conditions can the Seiler Colposcope Models 935, 955, and 985 help diagnose?
These colposcopes are designed to visually examine the cervix, vagina, and vulva for abnormalities such as dysplasia, lesions, or cervical cancer precursors. The built-in magnification and illumination systems enhance visibility of tissue surfaces, aiding clinicians in identifying early signs of gynecological concerns during routine or follow-up evaluations.
Are the Seiler Colposcope Models 935, 955, and 985 reusable or single-use devices?
These colposcopes are reusable medical devices. They require thorough cleaning and maintenance between uses to ensure hygiene and functionality. The manufacturer provides guidelines for proper care to extend the device’s lifespan and maintain diagnostic accuracy.
How do the models 935, 955, and 985 differ in terms of features?
The Seiler Colposcope Models 935, 955, and 985 are tailored to different clinical workflows and diagnostic needs. While the exact distinctions between models aren’t specified in the data, variations likely include differences in magnification ranges, illumination intensity, or additional accessories (e.g., camera compatibility or specialized lenses). Clinicians should refer to the manufacturer’s documentation for model-specific features.
What regulatory pathway does the Seiler Colposcope follow, and what does that mean for clinicians?
The Seiler Colposcope Models 935, 955, and 985 are classified under the FDA’s 510(k) clearance process, specifically as substantially equivalent to predicate devices. This classification means the device meets regulatory standards for Class II medical devices, ensuring it has undergone evaluation for safety and effectiveness. Clinicians can rely on this pathway as confirmation that the device adheres to established guidelines for diagnostic colposcopy.
How should the Seiler Colposcope be stored to maintain performance and sterility?
While the colposcopes are not sterile upon delivery, proper storage is critical to preserve their functionality and longevity. The manufacturer recommends following guidelines for handling and storage, including keeping the device in a clean, dry environment away from direct sunlight or extreme temperatures. Regular maintenance, as outlined in the user manual, will help prevent damage and ensure reliable performance during examinations.