# K993951: Spot Endoscopic Marker

- Pathway: 510(k) (Traditional)
- Applicant: Chek-Med Systems
- Decided: Feb 18, 2000 after 88 days
- Product code: NBG (Marker, Colon)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K153479: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (2016), 2 descendants of its own
- K182616: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (2018), 1 descendant of its own
- K251730: LIA Console  (542-7) (2025), 0 descendants of its own
- K042901: Endomark Sterile India Ink (2005), 0 descendants of its own

## Indications for use
Spot™ is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will be removed surgically within (30) thirty days.

Source page: https://510kreport.com/device/K993951
Methodology: https://510kreport.com/methodology