Identifiers
- 510(k) Number
- K181116 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 Convivo is an Endoscope, Neurological, which is substantially equivalent and has a device class of 2. It is used for in vivo pathology and provides real-time feedback on tissue microstructure through digital pathology consultation.
The Convivo is supplied with a sterile sheath and is used in a surgical setting, allowing cross-functional medical team members to remote-access in vivo images in the OR to support the surgeon. It has an FDA 510K authorization and is regulated under regulation number 882.1480.
Frequently asked questions
What is the Convivo used for?
The Convivo is used for in vivo pathology, providing real-time feedback on tissue microstructure through digital pathology consultation in a surgical setting.
Is the Convivo supplied sterile?
Yes, the Convivo is supplied with a sterile sheath, allowing for safe use in surgical procedures.
What regulatory authorization does the Convivo have?
The Convivo has an FDA 510K authorization, regulated under regulation number 882.1480, and is classified as a class 2 device.
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: ZEISS Convivo | ZEISS Medical Technology, CONVIVO - ZEISS Vision Care, Zeiss CONVIVO - In Vivo Pathology Suite - Medilex, Confocal Endomicroscope
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181116 | Class II | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
- FDA Applicant
- Carl Zeiss Meditec, AG
Sources (1)
- FDA 510(k) K181116 24 fields · synced Oct 6, 2026