Last synced on 10 January 2025 at 11:05 pm

ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081129
510(k) Type
Traditional
Applicant
SURGRX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/28/2008
Days to Decision
98 days
Submission Type
Summary

ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081129
510(k) Type
Traditional
Applicant
SURGRX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/28/2008
Days to Decision
98 days
Submission Type
Summary