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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Culdoscopic (And Accessories)
510(k) Number K151567
Device Name ENDOPLUS hand-held laparoscopic instruments
Applicant
Endoplus
750 Tower Rd., Suite A
Mundelein,  IL  60060
Applicant Contact Matthew Gudeman
Correspondent
Smith Assoicates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number884.4160
Classification Product Code
HFI  
Date Received06/10/2015
Decision Date 12/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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