510(k) K212860 ยท FDI Snare, Flexible
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Oct 7, 2021 |
| Received | Sep 8, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212860
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.