Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241
by Richard Wolf Medical Instruments Corp.
510(k) K000673
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000673 | Date26 May 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1690
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Hysteroscope (and Accessories) as classified under FDA regulation 884.1690. It functions as an operating sheath and insert designed for hysteroscopic procedures, facilitating visualization and access within the uterine cavity. The sheath provides a pathway for the hysteroscope while the insert aids in dilation and irrigation during diagnostic or therapeutic interventions. These components work together to enhance procedural precision and patient safety in obstetrics and gynecology settings.
The Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241, is intended for single-use in sterile conditions, as indicated by its regulatory submission. It is classified as a Class II device under FDA guidelines and has received FDA 510(k) clearance (K000673) under the Traditional 510(k) Review pathway. The device is supplied in sterile packaging and is compatible with standard hysteroscopic systems. Authorized for use in obstetrics/gynecology, it adheres to MRI safety standards for non-ferromagnetic materials. Storage instructions specify protection from contamination and extreme temperatures.
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Questions
AI-generated answers, 1 Oct 2026
What is the Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241, used for?
This device is designed for hysteroscopic procedures, providing a pathway for the hysteroscope while the insert aids in dilation and irrigation. It facilitates visualization and access within the uterine cavity during both diagnostic and therapeutic interventions in obstetrics and gynecology. The sheath and insert work together to improve procedural accuracy and patient safety.
How is the Hysteroscope Operating Sheath and Insert supplied, and is it sterile?
The device is supplied in sterile packaging, ensuring it is ready for immediate single-use in sterile conditions. This design adheres to medical best practices for minimizing infection risk during procedures.
Are the sheath and insert reusable, or are they intended for single-use?
The Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241, is explicitly intended for single-use only. This is supported by its regulatory submission and packaging specifications, which emphasize sterility and contamination prevention.
What storage instructions should be followed for this device?
The device must be stored in a clean, dry environment protected from contamination and extreme temperatures. Proper storage ensures the integrity of the sterile packaging and the functionality of the sheath and insert for their intended single-use application.
Is this device compatible with MRI equipment, and what safety measures are in place?
Yes, the Hysteroscope Operating Sheath and Insert adheres to MRI safety standards for non-ferromagnetic materials. This ensures it can be safely used in clinical settings where MRI compatibility is required, reducing the risk of interference or injury during imaging.