| K-number | K253888 |
| Device name | MOLLI 2 System |
| Applicant | Stryker Endoscopy |
| Product code | NEU |
| Device class | Class II |
| Decision date | Dec 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4300 |
The MOLLI 2 System is a surgical marking and guidance system consisting of a temporary implantable marker, delivery introducer, detection wand, and visualization tablet. It is intended to locate and mark non-palpable lesions during surgery by placing the marker percutaneously in soft tissue for temporary marking of surgical sites intended for removal, with the marker remaining implanted for greater than 30 days.
The MOLLI 2 System has identical technological characteristics to its predicate device (MOLLI 2 System, K240042) with a single exception: an additional warning in the Instructions for Use regarding the use of magnetized surgical tools during marker localization, as magnetic attraction can lead to marker dislodgement.
Not stated in this summary.
The subject device has the same indications for use and intended use as the predicate device. No design, software, or hardware changes were made beyond adding an informational warning in the user documentation. Since the risk control measure is informational mitigation only, no bench testing was necessary, and the device is substantially equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov