Henke-Sass, Wolf Piston Syringe (Norm-Jet)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101547 FDA 510(k)
- FDA Product Code
- FMF 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 Henke-Sass, Wolf Piston Syringe (Norm-Jet) is a medical device designed for the administration of medication. It operates on established principles for syringe-based delivery systems.
This device is available in both reusable and single-use configurations to support various clinical injection needs. It has received FDA 510(k) clearance under K101547.
Frequently asked questions
What is the primary purpose of the Henke-Sass, Wolf Piston Syringe?
The Norm-Jet piston syringe is designed for the administration of medication, utilizing established principles for syringe-based delivery systems to support clinical injection needs.
Is the Norm-Jet syringe intended for single-use or can it be reused?
This device is available in both reusable and single-use configurations, allowing clinicians to select the appropriate version based on their specific injection requirements.
What is the regulatory status of this device?
The Henke-Sass, Wolf Piston Syringe (Norm-Jet) has received FDA 510(k) clearance under K101547, confirming it is substantially equivalent to existing devices.
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: HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) (K101547) — FDA 510 (k ..., Syringes and needles - HenkeSassWolf, Products - HenkeSassWolf, Henke Gruppe – Paul Henke GmbH & Co. KG und project Kunststoff ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101547 | Class II | Active |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
Sources (1)
- FDA 510(k) K101547 24 fields · synced Oct 6, 2026