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)— 510(k) K212860

Name: FDA 510(k) clearance K212860
Creator: U.S. Food and Drug Administration
Published: 2021-10-07

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K212860 for 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), Substantially Equivalent on 2021-10-07. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-08
Decision date: 2021-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.