Last synced on 12 October 2025 at 8:21 pm

AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122580
510(k) Type
Traditional
Applicant
ENCISION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/9/2012
Days to Decision
78 days
Submission Type
Summary

AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122580
510(k) Type
Traditional
Applicant
ENCISION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/9/2012
Days to Decision
78 days
Submission Type
Summary