ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE

Laparoscope, Gynecologic (and Accessories)

ENDOTHERAPEUTICS

The following data is part of a premarket notification filed by Endotherapeutics with the FDA for Endoport 5mm Single-use Trocar And Sleeve.

Pre-market Notification Details

Device IDK860192
510k NumberK860192
Device Name:ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City,  CA  94063
ContactRussell B Thompson
CorrespondentRussell B Thompson
ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City,  CA  94063
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-22
Decision Date1986-03-17

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