Resheather Device-Metal Or Plastic, Resheater/ Needle Holder Device-Plastic
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K972705 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device consists of plastic, metal, or foam holders designed for placement at point-of-care. It enables healthcare workers to perform one-handed needle resheathing or temporary needle stabilization prior to disposal.
The device accommodates varying needle sheath sizes and provides surface-mountable stabilization. It is supplied as a non-sterile, reusable device intended for use in general hospital settings.
Frequently asked questions
What is the RESHEATHER device used for?
The RESHEATHER device is designed to enable healthcare workers to perform one-handed needle resheathing or temporary needle stabilization prior to disposal, allowing safer handling of used needles at the point of care in general hospital settings.
Is the RESHEATHER device sterile or non-sterile, and is it intended for single use or reuse?
The RESHEATHER device is supplied as a non-sterile device and is intended for reuse, meaning it can be cleaned and used multiple times in accordance with facility protocols for general hospital use.
What materials is the RESHEATHER device made from, and what needle sizes does it accommodate?
The RESHEATHER device consists of holders made from plastic, metal, or foam and is designed to accommodate varying needle sheath sizes, providing flexibility for different needle types used in clinical settings.
How is the RESHEATHER device supplied and where is it intended to be used?
The RESHEATHER device is supplied as a non-sterile, reusable unit designed for surface-mountable stabilization and is intended for use in general hospital settings at the point of care.
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: Resheather Device-metal or Plastic, Resheater/ Needle Holder Device ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972705 | Class II | Active |
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Manufacturer
- Manufacturer
- Sage Products, Inc.
Sources (1)
- FDA 510(k) K972705 24 fields · synced Sep 22, 2026