# K181116: Convivo

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Oct 25, 2018 after 181 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002788 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180270: Cellvizio 100 Series Systems with Confocal Miniprobes, Mauna Kea Technologies (2018). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K211156: CONVIVO In Vivo Pathology Suite (2021), 0 descendants of its own

## Indications for use
The ZEISS CONVIVO is a surgical endomicroscope intended for viewing intra-operative blood flow in the cerebral vascular area, including microvasculature and capillaries. The CONVIVO’s fiber optic scanner probe is placed in direct contact with tissue during cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, to create in-vivo confocal laser scanning images of the internal microstructure of tissues.

Source page: https://510kreport.com/device/K181116
Methodology: https://510kreport.com/methodology