510(k) K253888 ยท NEU Marker, Radiographic, Implantable
MOLLI 2 System
| Applicant | Stryker Endoscopy, San Jose CA, US |
| Decision | Substantially Equivalent, Dec 31, 2025 |
| Received | Dec 4, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253888
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 17, 2026 | Stryker Corporation MOLLI 2 System
System includes:
MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker
UDI (GTIN): 00850024195028
MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker
UDI Open, Classified |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.