Last synced on 24 May 2024 at 11:04 pm

ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213185
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
6/8/2022
Days to Decision
252 days
Submission Type
Summary

ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213185
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
6/8/2022
Days to Decision
252 days
Submission Type
Summary