INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP

Laparoscope, General & Plastic Surgery

INNERDYNE, INC.

The following data is part of a premarket notification filed by Innerdyne, Inc. with the FDA for Innerdyne Step Trocar Expandable Port, Step.

Pre-market Notification Details

Device IDK950632
510k NumberK950632
Device Name:INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
ClassificationLaparoscope, General & Plastic Surgery
Applicant INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
ContactRick Gaykowski
CorrespondentRick Gaykowski
INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-13
Decision Date1995-05-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521090736 K950632 000

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