Syringe Needle Remover (S.N.R.)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K972536 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 Syringe Needle Remover (S.N.R.) is a mechanical device designed for the disposal of medical sharps. It functions by removing needles from syringes to facilitate safe disposal, thereby reducing the risk of accidental needlestick injuries. The device is intended for use in both healthcare facilities and home environments.
The Syringe Needle Remover (S.N.R.) is a Class 2 General Hospital device with product code FMI. It is manufactured by Post Medical, Inc. and was cleared through the Traditional 510(k) pathway after a 68-day FDA review. The device is supplied as a single-use or reusable product depending on the model, and storage requirements are not specified in the provided data.
Frequently asked questions
What is the Syringe Needle Remover (S.N.R.) used for?
The S.N.R. is a mechanical device designed for the safe disposal of medical sharps by removing needles from syringes, which helps reduce the risk of accidental needlestick injuries in both healthcare facilities and home environments.
Is the Syringe Needle Remover single-use or reusable?
The S.N.R. is available as either a single-use or reusable product depending on the model selected, allowing flexibility for different usage scenarios and institutional requirements.
What are the regulatory specifications for the S.N.R.?
The Syringe Needle Remover is classified as a Class 2 General Hospital device with product code FMI. It was cleared through the Traditional 510(k) pathway after a 68-day FDA review with K number K972536.
Where can the S.N.R. be used?
The device is intended for use in both healthcare facilities and home environments, making it versatile for various settings where safe sharps disposal is needed.
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: SYRINGE NEEDLE REMOVER (S.N.R.) (K972536) — FDA 510 (k) | Innolitics, K972536 FDA 510 (k) - SYRINGE NEEDLE REMOVER (S.N.R.), Buy Needle Disposal Containers at Post Medical | Made in the USA, Post Medical, Inc. FDA 510 (k) Products (1983-1999)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972536 | Class II | Active |
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Manufacturer
- Manufacturer
- Post Medical, Inc.
Sources (1)
- FDA 510(k) K972536 24 fields · synced Sep 28, 2026