PointerShell Universal, PointerShell LS
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Fiagon GmbH
Identifiers
- 510(k) Number
- K160479 FDA 510(k)
- FDA Product Code
- PGW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PointerShell Universal and PointerShell LS are Ear, Nose, and Throat Stereotaxic Instruments, designed for precise localization and guidance in ENT procedures. These devices feature adjustable, modular components to accommodate various anatomical landmarks, ensuring accurate targeting for diagnostic or therapeutic interventions in the head and neck region.
Supplied as reusable instruments, the PointerShell Universal and LS are intended for use in clinical settings such as operating rooms or procedural suites. They are classified as Class II devices under FDA regulations and comply with Medical Device Regulation (MDR) standards. Sterilization and maintenance protocols must adhere to manufacturer guidelines to ensure functionality and patient safety. No MRI safety information is specified, and their use is governed by the applicable FDA 510(k) clearance and MDR authorization
Frequently asked questions
Are the PointerShell Universal and PointerShell LS instruments designed for single-use or reusable applications in clinical settings?
The PointerShell Universal and PointerShell LS are reusable instruments, intended for use in clinical environments like operating rooms or procedural suites. Since they are reusable, strict adherence to the manufacturer’s sterilization and maintenance protocols is required to ensure functionality and patient safety. No specific sterilization method is mentioned, so facility protocols should align with the manufacturer’s guidelines.
What anatomical regions or procedures are these instruments primarily intended to assist with?
The PointerShell Universal and PointerShell LS are Ear, Nose, and Throat (ENT) Stereotaxic Instruments, designed for precise localization and guidance during ENT procedures. Their adjustable, modular components allow for accurate targeting of anatomical landmarks in the head and neck region, supporting both diagnostic and therapeutic interventions. They are not limited to a single procedure but are versatile for ENT-specific applications.
How do I determine if a specific PointerShell model is compatible with my facility’s existing equipment or workflow?
The PointerShell Universal and PointerShell LS feature adjustable, modular components, which means they can be configured to accommodate various anatomical landmarks. While the exact compatibility with other equipment isn’t detailed, their design emphasizes flexibility for ENT procedures. Facilities should consult the manufacturer’s documentation or technical support to confirm integration with their specific workflows or imaging systems (e.g., fluoroscopy or navigation tools).
What regulatory pathways have these devices undergone, and how does that affect their use in my facility?
The PointerShell Universal and PointerShell LS have undergone FDA 510(k) clearance (with a Special Advisory Committee review in Neurology) and comply with Medical Device Regulation (MDR) standards in the EU. Their classification as Class II devices under FDA regulations indicates a moderate risk level, requiring adherence to established manufacturing and quality control standards. Facilities should ensure their purchasing and use align with the manufacturer’s approved indications and the regulatory requirements of their jurisdiction.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160479 | Class II | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (2)
- FDA 510(k) K160479 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026