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510(k) Data Aggregation
K Number
K152598Device Name
Endo Keeper
Manufacturer
NELIS
Date Cleared
2016-03-17
(188 days)
Product Code
OTJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NELIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
This device is single use and sterilized.
Device Description
The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.
The Endo Keeper is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.
The Urethane Forming Sheet (components of the Endo Keeper) function is to cover the incision site of abdominal.
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K Number
K141715Device Name
GLOVE PORT
Manufacturer
NELIS
Date Cleared
2015-03-25
(273 days)
Product Code
GCJ, OTJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NELIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
Device Description
The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.
The GLOVE PORT is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.
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