Identifiers
- 510(k) Number
- K233391 FDA 510(k)
- FDA Product Code
- GWG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1480 FDA 510(k)
- Regulation Number
- 882.1480 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The cCeLL - In Vivo is a neurological endoscope designed for in vivo imaging of tissue microstructure. It functions as an optical scanner probe that captures near-infrared (NIR) fluorescence images, specifically of indocyanine green (ICG) dye, to visualize tissue characteristics during surgical procedures. This device aids in real-time assessment of tissue properties, supporting intraoperative decision-making in neurosurgery.
The cCeLL - In Vivo is supplied as a reusable, hand-held probe intended for direct contact with tissue. It is classified as a Class II device under FDA regulations and has received 510(k) clearance through a Traditional pathway, with the Neurology Advisory Committee overseeing its review. The device is not sterile at time of shipment and must be sterilized prior to use. No specific MRI safety information is provided, and its use is limited to intraoperative settings in adult neurosurgical procedures.
Frequently asked questions
What is the cCeLL - In Vivo designed for?
The cCeLL - In Vivo is a neurological endoscope specifically designed for in vivo imaging of tissue microstructure. It uses near-infrared (NIR) fluorescence imaging to visualize indocyanine green (ICG) dye, allowing surgeons to assess tissue characteristics in real-time during neurosurgical procedures. This aids in intraoperative decision-making by providing immediate feedback on tissue properties.
How is the cCeLL - In Vivo supplied and what are its sterility requirements?
The cCeLL - In Vivo is supplied as a reusable, hand-held probe intended for direct contact with tissue. It is not sterile at the time of shipment and must be sterilized prior to use. Sterilization is a critical step to ensure patient safety before intraoperative application.
Is the cCeLL - In Vivo suitable for MRI environments?
The device does not provide specific MRI safety information, so its use is limited to intraoperative settings only. Clinicians should confirm compatibility with their MRI equipment and protocols before use in hybrid or MRI-guided procedures.
What regulatory pathway was followed for the cCeLL - In Vivo?
The cCeLL - In Vivo received FDA 510(k) clearance through the Traditional pathway, with the Neurology Advisory Committee overseeing its review. It is classified as a Class II device under FDA regulations, indicating it poses minimal potential risk but requires specific controls to ensure safety and effectiveness.
Can the cCeLL - In Vivo be used in pediatric neurosurgery?
The device is intended for adult neurosurgical procedures only, as specified in its design and regulatory documentation. There are no indications or clinical data supporting its use in pediatric patients, so its application should be restricted to adult cases unless further validation is provided.
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: Vpix Medical, PDF VPIX Medical, Inc. Dawn N. Norman, M.S. Partner MRC Global, LLC Trade ..., Vpix Medical, cCeLL - In vivo by VPIX Medical, Inc. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233391 | Class II | Active |
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Manufacturer
- Manufacturer
- VPIX Medical, Inc.
Sources (1)
- FDA 510(k) K233391 24 fields · synced Oct 1, 2026