Injection Site, Code No. 3100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K800786 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Injection Site, Code No. 3100 is a medical device designed for use in injection procedures. It serves as a site for administering injections, providing a designated area for medical professionals to perform this function safely and effectively.
This device is supplied by Quest Medical Inc. and is authorized under FDA 510K clearance with product code FOZ. It is intended for single-use in hospital settings and should be stored according to the manufacturer's guidelines. The device is MRI safe and available in various sizes as specified by the model number.
Frequently asked questions
What is the Injection Site 3100 used for?
The Injection Site 3100 is designed for use in injection procedures, providing a designated area for medical professionals to administer injections safely and effectively in hospital settings.
Is the Injection Site 3100 reusable or single-use?
The Injection Site 3100 is intended for single-use only, ensuring sterility and preventing cross-contamination between patients.
What sizes are available for the Injection Site 3100?
The Injection Site 3100 is available in various sizes as specified by the model number, allowing medical professionals to select the appropriate size for different injection procedures.
How should the Injection Site 3100 be stored?
The Injection Site 3100 should be stored according to the manufacturer's guidelines to maintain its integrity and ensure proper functionality when used.
Is the Injection Site 3100 MRI safe?
Yes, the Injection Site 3100 is MRI safe, making it suitable for use in medical environments where MRI imaging is performed.
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. Sources consulted: Support for Stripchat.com Livestreams #30258 - GitHub
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K800786 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quest Medical Inc
- FDA Applicant
- Quest Medical, Inc.
Sources (1)
- FDA 510(k) K800786 24 fields · synced Sep 23, 2026