Last synced on 14 November 2025 at 11:06 pm

SoftFix Balloon Trocar

Page Type
Cleared 510(K)
510(k) Number
K211577
510(k) Type
Traditional
Applicant
Unimax Medical Systems Inc.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
11/5/2021
Days to Decision
168 days
Submission Type
Summary

SoftFix Balloon Trocar

Page Type
Cleared 510(K)
510(k) Number
K211577
510(k) Type
Traditional
Applicant
Unimax Medical Systems Inc.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
11/5/2021
Days to Decision
168 days
Submission Type
Summary