Altaviz Intravitreal Syringe
FDA 510(k)Class II (US FDA 510(k))
by Altaviz, LLC
Identifiers
- 510(k) Number
- K243322 FDA 510(k)
- FDA Product Code
- QLY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Altaviz Intravitreal Syringe is an ophthalmic syringe designed for precise administration of intraocular medications. It is classified as a Class 2 device under FDA regulations (product code QLY) and is intended for use in general hospital settings, adhering to standards for sterile, single-use injection systems in ophthalmic procedures.
This three-piece syringe is supplied sterile via irradiation and includes a graduated scale in milliliters. It is intended for reusable review panel classification under the FDA’s Traditional 510(k) pathway (K243322) and complies with particulate matter testing requirements. Storage and handling follow standard sterile medical device protocols to ensure integrity before use.
Frequently asked questions
What types of intraocular medications can the Altaviz Intravitreal Syringe be used with, and how does its design support precise administration?
The Altaviz Intravitreal Syringe is specifically designed for the precise administration of intraocular medications in ophthalmic procedures. Its three-piece construction and graduated millimeter scale allow clinicians to accurately measure and deliver small volumes, which is critical for intraocular injections where dosage precision is essential. While the device itself does not specify compatible medications, its sterile, single-use design ensures safety and reliability for common intraocular therapies like anti-VEGF agents or corticosteroids.
Is the Altaviz Intravitreal Syringe reusable, and if not, how should it be handled to maintain sterility before use?
The Altaviz Intravitreal Syringe is sterile, single-use only, as indicated by its classification as a sterile injection system for ophthalmic procedures. To maintain sterility before use, it must be stored in its original packaging, protected from contamination, and handled using aseptic techniques. The device is irradiated for sterility, so opening or repackaging the syringe voids its sterile status. Always follow standard sterile medical device protocols, including checking expiration dates and ensuring the packaging remains intact.
What storage conditions are recommended for the Altaviz Intravitreal Syringe to ensure its integrity before clinical use?
The Altaviz Intravitreal Syringe should be stored according to standard sterile medical device protocols. This includes keeping it in its original, unopened packaging to preserve sterility, protecting it from physical damage, extreme temperatures, and direct light. The device is irradiated for sterility, so exposure to moisture or contamination—such as opening the packaging prematurely—could compromise its integrity. Always store it in a clean, dry environment as directed by the manufacturer’s instructions.
How does the FDA’s classification and clearance process apply to this syringe, and what does the product code QLY indicate about its intended use?
The Altaviz Intravitreal Syringe is classified as a Class 2 device under FDA regulations with the product code QLY, which categorizes it as an *ophthalmic syringe*. This classification means it undergoes a Traditional 510(k) review to demonstrate substantial equivalence to a legally marketed predicate device. The clearance (K243322) confirms it meets FDA standards for sterile, single-use injection systems in general hospital settings, though the product code itself does not define clinical indications—only the administrative filing category.
Are there multiple sizes or models of the Altaviz Intravitreal Syringe, and if so, how can a clinician determine which one to use for a specific procedure?
The data provided lists multiple FEI numbers (3026478941; 3008397795; etc.), which typically correspond to different lot or batch identifiers rather than distinct syringe sizes or models. However, the device itself is described as a three-piece syringe with a graduated scale in milliliters, implying a standard design for intraocular use. Clinicians should refer to the manufacturer’s labeling or procedural guidelines to confirm compatibility with their specific medication volume requirements, as the syringe’s precision scale aids in accurate dosing regardless of model.
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: PDF Altaviz, LLC ℅ Sean Griffin President Allied Regulatory Consulti, K243322 FDA 510(k) - Altaviz Intravitreal Syringe | Altaviz, LLC, Altaviz Intravitreal Syringe (K243322) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243322 | Class II | Active |
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Manufacturer
- Manufacturer
- Altaviz, LLC
Sources (1)
- FDA 510(k) K243322 24 fields · synced Sep 19, 2026