# K253888: MOLLI 2 System

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Dec 31, 2025 after 27 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K023694 (2003). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240042: MOLLI 2 System, Molli Surgical, Inc. (2024) Summary page 5.

## Recalls of this device
- Jan 21, 2026 · Class II · Z-1427-2026: Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.

## Indications for use
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can be implanted for greater than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI Systems (MOLLI System and MOLLI 2 System)), the MOLLI Marker is located and surgically removed with the target tissue. The MOLLI Systems (MOLLI System and MOLLI 2 System) are intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

Source page: https://510kreport.com/device/K253888
Methodology: https://510kreport.com/methodology