FROG Forceps Valve VAL1-F1-100
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221264 FDA 510(k)
- FDA Product Code
- ODC 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 FROG Forceps Valve VAL1-F1-100 is an Endoscope Channel Accessory, designed as a valve mechanism for controlling fluid flow within endoscopic instruments. It facilitates precise manipulation of fluids during procedures, ensuring optimal visibility and access within the gastrointestinal or urinary tract.
This device is supplied as a reusable accessory, intended for use in clinical settings such as gastroenterology and urology. It is classified as a Class II medical device under FDA regulations and adheres to the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. The valve is compatible with MRI environments and requires proper sterilization and maintenance as per manufacturer guidelines.
Frequently asked questions
What clinical specialties is the FROG Forceps Valve primarily used in, and why is it beneficial for those fields?
The FROG Forceps Valve (VAL1-F1-100) is designed for use in gastroenterology and urology, as indicated by its advisory committee classification and medical specialty description. It controls fluid flow within endoscopic instruments, ensuring clear visibility and precise access during procedures in the gastrointestinal or urinary tract. This helps clinicians maintain optimal working conditions during interventions like biopsies, irrigations, or instrument exchanges.
Is the FROG Forceps Valve reusable, and what maintenance or sterilization steps are required?
Yes, the FROG Forceps Valve is supplied as a reusable accessory for clinical settings. Since it is reusable, it must be properly sterilized and maintained according to the manufacturer’s guidelines to ensure safety and functionality. The device is compatible with MRI environments, but sterilization protocols (e.g., autoclave, chemical sterilization) should align with the manufacturer’s recommendations to preserve its performance.
How do I determine if this valve is compatible with my existing endoscopic instruments?
The FROG Forceps Valve is classified as an Endoscope Channel Accessory, meaning it is designed to interface with standard endoscopic instruments used in gastroenterology and urology. While the exact compatibility depends on your specific device’s channel size and design, the valve’s reusable and modular nature suggests it is intended for general use with compatible endoscopes. For confirmation, consult the manufacturer’s documentation or contact their technical support team with your instrument’s specifications.
What regulatory pathways has the FROG Forceps Valve followed, and what does that mean for its use in clinical practice?
The FROG Forceps Valve has undergone FDA 510(k) clearance, the Medical Device Directive (MDD), and the Medical Device Regulation (MDR). This means it has been evaluated for safety and effectiveness according to European and U.S. regulatory standards. Clinicians can rely on its compliance with these frameworks, though local regulations (e.g., licensing, hospital procurement policies) may still apply. The device’s classification as Class II under FDA guidelines indicates moderate risk, with additional controls in place.
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 (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221264 | Class II | Active |
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Manufacturer
- Manufacturer
- FUJIFILM medwork GmbH
Sources (2)
- FDA 510(k) K221264 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026