Last synced on 10 January 2025 at 11:05 pm

CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211579
510(k) Type
Traditional
Applicant
Bolder Surgical, LLC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/7/2021
Days to Decision
109 days
Submission Type
Summary

CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211579
510(k) Type
Traditional
Applicant
Bolder Surgical, LLC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/7/2021
Days to Decision
109 days
Submission Type
Summary