Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System
510(k) K070964
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK070964 | Date18 May 2007 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- HIB
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Kleenspec Single-Use Vaginal Speculum and 790 Series Cordless Illumination System is a single-use, nonmetal vaginal speculum designed for obstetrics and gynecology examinations. It combines a disposable speculum with a cordless illumination system to enhance visibility during internal examinations, ensuring clear visualization of the vaginal and cervical areas without the need for external light sources.
This system is intended for single-use in clinical settings and is supplied sterile. The cordless illumination system operates independently, providing adjustable brightness to improve diagnostic accuracy. Authorized under FDA 510K and MDR, it adheres to Class II medical device regulations and is classified under the product code HIB for vaginal speculums. Storage and handling follow standard sterile medical device protocols to maintain integrity and usability.
Other devices from Welch Allyn, Inc.
Questions
AI-generated answers, 18 Sep 2026
What clinical specialties is the Kleenspec Single-Use Vaginal Speculum and 790 Series Cordless Illumination System designed for?
The device is specifically designed for use in obstetrics and gynecology examinations, as indicated by its classification under the medical specialty description 'Obstetrics/Gynecology' and the advisory committee review process (OB). This makes it suitable for clinical settings where vaginal and cervical examinations are performed.
Is the Kleenspec Single-Use Vaginal Speculum reusable or intended for single-use only? Why?
The device is explicitly labeled as single-use, meaning it is intended for one-time clinical use only. This is reinforced by the product’s sterile supply and the manufacturer’s design to avoid reuse, ensuring patient safety and maintaining sterility standards.
How does the cordless illumination system enhance the examination process?
The cordless illumination system is integrated into the speculum to provide adjustable brightness, eliminating the need for external light sources. This improves visibility of the vaginal and cervical areas during examinations, which can enhance diagnostic accuracy and reduce the need for repositioning or additional tools.
What storage and handling guidelines should be followed for the Kleenspec device?
The device must be stored and handled according to standard sterile medical device protocols to preserve its integrity and usability. Since it is supplied sterile, it should remain unopened until use and stored in a clean, dry environment to prevent contamination.
What regulatory pathways has the Kleenspec Single-Use Vaginal Speculum and 790 Series Cordless Illumination System undergone?
The device has been authorized through the FDA 510K pathway and adheres to the Medical Device Regulation (MDR) in the EU. It is classified as a Class II medical device under the product code HIB for vaginal speculums, with a decision of 'Substantially Equivalent' for its regulatory submission.