Last synced on 10 January 2025 at 11:05 pm

APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191234
510(k) Type
Traditional
Applicant
Erbe Elektromedizin GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
12/20/2019
Days to Decision
226 days
Submission Type
Summary

APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191234
510(k) Type
Traditional
Applicant
Erbe Elektromedizin GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
12/20/2019
Days to Decision
226 days
Submission Type
Summary