Last synced on 20 January 2023 at 11:05 pm

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180302
510(k) Type
Traditional
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/24/2018
Days to Decision
264 days
Submission Type
Summary

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180302
510(k) Type
Traditional
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/24/2018
Days to Decision
264 days
Submission Type
Summary