Last synced on 25 November 2022 at 11:04 pm

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)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212860
510(k) Type
Special
Applicant
Steris Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/7/2021
Days to Decision
29 days
Submission Type
Summary

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)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212860
510(k) Type
Special
Applicant
Steris Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/7/2021
Days to Decision
29 days
Submission Type
Summary