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U-IGNITE Bladeless Trocar

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162387
510(k) Type
Traditional
Applicant
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/11/2017
Days to Decision
139 days
Submission Type
Summary