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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K860192
Device Name ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE
Applicant
Endotherapeutics
654 Bair Island Rd.
Suite 209
Redwood City,  CA  94063
Applicant Contact RUSSELL B THOMPSON
Correspondent
Endotherapeutics
654 Bair Island Rd.
Suite 209
Redwood City,  CA  94063
Correspondent Contact RUSSELL B THOMPSON
Regulation Number884.1720
Classification Product Code
HET  
Date Received01/22/1986
Decision Date 03/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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