Last synced on 20 January 2023 at 11:05 pm

BenestaTM Tissue Removal Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192811
510(k) Type
Traditional
Applicant
Caldera Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/23/2020
Days to Decision
389 days
Submission Type
Statement

BenestaTM Tissue Removal Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192811
510(k) Type
Traditional
Applicant
Caldera Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/23/2020
Days to Decision
389 days
Submission Type
Statement