Medivision Hysteroscope
by Medivision Scope Service Center, Inc.
510(k) K982659
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982659 | Date7 Oct 1998 | 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- Withdrawn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
The Medivision Hysteroscope is a diagnostic and therapeutic device classified as a Hysteroscope (and Accessories) under FDA product code HIH. It is designed for visual inspection, diagnosis, and treatment of the uterine cavity, fallopian tubes, and cervical canal. The device enables minimally invasive procedures such as biopsy sampling, dilation, and removal of polyps or other abnormalities. Its optical system provides real-time imaging for precise interventions in gynecological care.
Used in clinical settings such as outpatient clinics, hospitals, and specialized gynecology centers, the Medivision Hysteroscope is intended for single-use or reusable applications, depending on the model and accessories. It is regulated under FDA 510(k) clearance (K982659) and falls under Class II – Special Controls for obstetrics/gynecology procedures. The device is supplied sterile or non-sterile based on model specifications, with various sizes and configurations available to accommodate different patient anatomies. Storage and handling follow standard medical device protocols to maintain sterility and functionality.
Other devices from Medivision Scope Service Center, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Medivision Hysteroscope used for in clinical practice?
The Medivision Hysteroscope is designed for visual inspection, diagnosis, and treatment of the uterine cavity, fallopian tubes, and cervical canal. Clinicians use it for minimally invasive procedures like biopsy sampling, dilation, and removal of polyps or other abnormalities. Its optical system provides real-time imaging, allowing precise interventions in gynecological care.
How is the Medivision Hysteroscope supplied, and what sterility options are available?
The Medivision Hysteroscope is supplied in either sterile or non-sterile configurations, depending on the specific model and accessories. Sterility ensures safety for single-use applications, while non-sterile models may require reprocessing for reusable settings. Always follow manufacturer guidelines for handling and storage to maintain integrity.
Are there different sizes or models to accommodate varying patient anatomies?
Yes, the Medivision Hysteroscope comes in multiple sizes and configurations to adapt to different patient anatomies. This flexibility ensures optimal visualization and procedural success across diverse clinical scenarios. Refer to the product specifications for detailed sizing options.
Can the Medivision Hysteroscope be reused, or is it intended for single-use?
The Medivision Hysteroscope can be used either as a single-use device or as a reusable instrument, depending on the model and accessories selected. Reusable models require proper cleaning, disinfection, and sterilization per medical device protocols to prevent contamination and ensure patient safety.
What storage and handling protocols should be followed for the Medivision Hysteroscope?
Storage and handling must adhere to standard medical device protocols to preserve sterility and functionality. Sterile models should remain in sealed packaging until use, while reusable models require careful cleaning, disinfection, and storage in a clean, dry environment. Always follow the manufacturer’s instructions for optimal device performance.