Identifiers
- 510(k) Number
- K253888 FDA 510(k)
- FDA Product Code
- NEU FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MOLLI 2 System is a wire-free, radiation-free marker for soft-tissue lesion localization, classified as a radiographic, implantable marker. It combines an introducer needle with a preloaded magnetic marker and a handheld guidance system (wand and tablet) to precisely locate implanted markers during surgical procedures.
The system is intended for single-use in surgical settings and has received FDA 510(k) clearance under product code NEU, classified as Class II with special controls. It is supplied sterile and designed for use in procedures requiring soft-tissue lesion localization, with no radiation exposure. The magnetic marker and guidance system ensure accurate identification without the need for wires or radioactive seeds.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MOLLI | Stryker, PDF MOLLI 2 User Manual - cdn1.get-qr.com, MOLLI 2 System (K253888) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253888 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K253888 24 fields · synced Sep 20, 2026