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CiRX Single use electrosurgical pencil with non-coated and coated electrode

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213786
510(k) Type
Traditional
Applicant
Ningbo Shun Ye Medical Company, Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
6/27/2022
Days to Decision
203 days
Submission Type
Summary

CiRX Single use electrosurgical pencil with non-coated and coated electrode

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213786
510(k) Type
Traditional
Applicant
Ningbo Shun Ye Medical Company, Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
6/27/2022
Days to Decision
203 days
Submission Type
Summary