Identifiers
- 510(k) Number
- K091600 FDA 510(k)
- FDA Product Code
- FGC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Directvision Guide System is a urethroscope, a medical device used for visual examination of the urethra. It is designed to provide direct visualization during urological procedures.
The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is used in clinical settings such as hospitals and outpatient facilities, and its regulatory authorization is based on FDA 510(k) clearance under product code FGC, with classification as a Class II device.
Frequently asked questions
What is the Directvision Guide System used for?
The Directvision Guide System is a urethroscope designed for visual examination of the urethra, providing direct visualization during urological procedures in clinical settings such as hospitals and outpatient facilities.
Is the Directvision Guide System sterile when supplied?
The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user, meaning it must be processed according to validated reprocessing instructions before each use.
Can the Directvision Guide System be reused?
Yes, the Directvision Guide System is designed for reusable use, provided it undergoes proper cleaning and sterilization by the user following validated reprocessing procedures to ensure safety and effectiveness between uses.
What regulatory pathway was used for the Directvision Guide System?
The device received FDA 510(k) clearance under product code FGC, with a classification as a Class II device, based on a traditional submission demonstrating substantial equivalence to a legally marketed predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091600 | Class II | Active |
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Manufacturer
- Manufacturer
- Percuvision, LLC
Sources (1)
- FDA 510(k) K091600 24 fields · synced Sep 23, 2026