Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043304 FDA 510(k)
- FDA Product Code
- LHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Q-Cap Needle-Free Reconstitution 13mm Vial Adapter, Model 6100-01, is a needle-free device designed for the withdrawal, reconstitution, and transfer of pharmaceutical solutions from 13mm vials into an injection syringe. It eliminates the need for traditional needle-based procedures, reducing the risk of needle-stick injuries and contamination during the preparation of injectable medications such as menotropins or urofollitropin.
This device is intended for use in general hospital settings and is supplied as a single-use, sterile component. It adheres to FDA 510(k) clearance under the classification of General Hospital devices and is classified as a Class II medical device. The adapter is compatible with standard 13mm vial sizes and is intended for one-time use per vial to ensure sterility and safety.
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: Q-cap Needle-free Reconstitution 13mm Vial Adapter, Model 6100-01 ..., Q-cap Needle-free Reconstitution 13mm Vial Adapter, Model 6100-01 ..., Q-cap Needle-free Reconstitution 13mm Vial Adapter, Model 6100-01, Q-cap Needle-free Reconstitution 13mm Vial Adapter, Model 6100-01
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043304 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioject Medical Technologies, Inc.
Sources (1)
- FDA 510(k) K043304 24 fields · synced Sep 19, 2026