Injection Site

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K932446 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the Injection Site device used for?

  The Injection Site is a sterile barrier designed to protect injection sites during intravenous (IV) or subcutaneous (SC) administration of fluids or medications. It creates a controlled environment to minimize contamination and infection risks, ensuring a cleaner needle insertion area.

• Is the Injection Site device single-use or reusable?

  The Injection Site is intended for single-use only. This design choice aligns with infection control best practices, as reuse could compromise sterility and increase contamination risks during subsequent procedures.

• What type of clinical settings is this device approved for?

  The Injection Site is approved for use in general hospital settings. Its regulatory classification under FDA Product Code FPA and clearance via 510(k) K932446 confirms suitability for standard hospital environments where IV or SC injections are administered.

• How is the Injection Site device supplied?

  The device is supplied as a sterile, single-use item. While specific packaging details aren’t provided in the regulatory data, its sterile barrier function requires careful handling to maintain integrity until immediate use.

• Are there any special storage requirements for the Injection Site?

  The Injection Site should be stored according to standard sterile medical device protocols. Since it is single-use and sterile, it must be kept in its original packaging until use to prevent contamination. Avoid exposure to extreme temperatures or moisture.