Optivia Hysteroscopic Introducer, Optivia Steerable Working Channel
510(k) K053583
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053583 | Date31 Mar 2006 | 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- Withdrawn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 Optivia Hysteroscopic Introducer with Steerable Working Channel is a hysteroscopic device designed for diagnostic and operative hysteroscopic procedures. It serves as an introducer to establish and maintain uterine distention while providing controlled access for hysteroscopic instruments within the uterine cavity. The steerable working channel enhances precision in positioning instruments, improving visualization and procedural accuracy.
This device is intended for single-use in obstetrics and gynecology settings. Supplied sterile, it is used in conjunction with hysteroscopic instruments for diagnostic and operative procedures. The device is FDA-cleared under 510(k) regulation 884.1690 and classified as a Class II medical device. Proper storage and handling are required to maintain sterility and functionality.
Optivia Hysteroscopic Introducer with Steerable Working Channel
Questions
AI-generated answers, 1 Oct 2026
What is the Optivia Hysteroscopic Introducer with Steerable Working Channel used for?
This device is designed for diagnostic and operative hysteroscopic procedures. It establishes and maintains uterine distention while offering controlled access for hysteroscopic instruments, enhancing precision and visualization within the uterine cavity. The steerable working channel allows clinicians to position instruments with greater accuracy, improving the outcomes of procedures like biopsies, polyp removal, or fibroid treatment.
How is the Optivia Hysteroscopic Introducer supplied, and is it sterile?
The device is supplied sterile and intended for single-use only. Sterility is maintained through proper manufacturing processes, ensuring it is ready for immediate use in clinical settings without additional sterilization. This design reduces the risk of contamination and simplifies workflow for clinicians.
Is this device reusable, or is it meant for one-time use?
The Optivia Hysteroscopic Introducer is explicitly designed for single-use only. Single-use devices minimize cross-contamination risks between patients and eliminate the need for reprocessing, which can introduce errors or compromise sterility. This aligns with best practices in obstetrics and gynecology for patient safety.
What regulatory approval does this device hold, and how is it classified?
The device is FDA-cleared under the 510(k) regulation (K053583) and classified as a Class II medical device. This classification indicates it poses moderate risk and requires premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. The clearance confirms it meets safety and effectiveness standards for its intended use in hysteroscopic procedures.
How should the Optivia Hysteroscopic Introducer be stored to maintain its functionality?
Proper storage is critical to preserve sterility and functionality. The device should be stored in its original, sealed packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoid exposure to chemicals or contaminants that could compromise the integrity of the sterile barrier. Follow manufacturer instructions for shelf-life and expiration dates to ensure optimal performance during use.