Last synced on 10 January 2025 at 11:05 pm

Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161558
510(k) Type
Traditional
Applicant
BOVIE MEDICAL CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/29/2016
Days to Decision
53 days
Submission Type
Summary

Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161558
510(k) Type
Traditional
Applicant
BOVIE MEDICAL CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/29/2016
Days to Decision
53 days
Submission Type
Summary