Last synced on 25 November 2022 at 11:04 pm

NovoFlow Reinforced Ureteral Stent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213186
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
2/16/2022
Days to Decision
140 days
Submission Type
Summary

NovoFlow Reinforced Ureteral Stent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213186
510(k) Type
Traditional
Applicant
Coloplast Corp
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
2/16/2022
Days to Decision
140 days
Submission Type
Summary