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HandX Instrument - Monopolar Spatula

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222011
510(k) Type
Special
Applicant
Human Xtensions Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
1/12/2023
Days to Decision
189 days
Submission Type
Summary