Last synced on 10 January 2025 at 11:05 pm

CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202114
510(k) Type
Traditional
Applicant
Bolder Surgical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/6/2020
Days to Decision
68 days
Submission Type
Summary

CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202114
510(k) Type
Traditional
Applicant
Bolder Surgical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/6/2020
Days to Decision
68 days
Submission Type
Summary