Identifiers
- 510(k) Number
- K951898 FDA 510(k)
- FDA Product Code
- HIB 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 Versa-Vu is a vaginal speculum that is nonmetal in construction. It is designed for use in obstetrics and gynecology examinations and procedures.
The device is supplied in various sizes as indicated by the multiple registration numbers. It is a Class II medical device that received FDA 510(k) clearance with the number K951898 in 1995. The device is manufactured by CooperSurgical, Inc.
Frequently asked questions
What is the Versa-Vu speculum used for?
The Versa-Vu is a nonmetal vaginal speculum designed specifically for use in obstetrics and gynecology examinations and procedures. Its construction provides an alternative to traditional metal speculums for these medical applications.
How is the Versa-Vu speculum supplied?
The Versa-Vu is supplied in various sizes as indicated by the multiple registration numbers. This size variety allows clinicians to select the appropriate speculum for different patient anatomies and procedural needs.
What is the regulatory status of the Versa-Vu speculum?
The Versa-Vu is a Class II medical device that received FDA 510(k) clearance with number K951898 in 1995. It is manufactured by CooperSurgical, Inc. and is substantially equivalent to other vaginal speculums on the market.
Is the Versa-Vu speculum reusable or single-use?
The device data does not specify whether the Versa-Vu is designed for single-use or reuse. As a Class II medical device, its intended use pattern would be determined by the manufacturer's instructions and facility protocols.
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: VERSA-VU 510 (k) K951898 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951898 | Class II | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA 510(k) K951898 24 fields · synced Sep 22, 2026