# K042901: Endomark Sterile India Ink

- Pathway: 510(k) (Traditional)
- Applicant: Pmt Corp.
- Decided: Mar 16, 2005 after 147 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
Longest line of descent: 1 generation back to K993951 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993951: Spot Endoscopic Marker, Chek-Med Systems (2000) Summary page 1.

## Indications for use
The EndomarkTM Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.

Source page: https://510kreport.com/device/K042901
Methodology: https://510kreport.com/methodology