# K223107: MOLLI 2

- Pathway: 510(k) (Traditional)
- Applicant: Molli Surgical, Inc.
- Decided: Jan 18, 2023 after 110 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K023694 (2003). 25 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210600: MOLLI, Molli Surgical, Inc. (2021) Summary page 4.

## Most influential descendants
- K231579: MOLLI 2 (2023), 3 descendants of its own
- K240042: MOLLI 2 System (2024), 1 descendant of its own
- K253888: MOLLI 2 System (2025), 0 descendants of its own
- K234149: MOLLI 2 System (2024), 0 descendants of its own

## 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 only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue. The MOLLI 2 System is 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/K223107
Methodology: https://510kreport.com/methodology