FDA.reportPublic FDA data

510(k) K072125

Device
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
Applicant
Ndo Surgical, Inc.
510(k) number
K072125
Product code
ODE
Decision
Substantially Equivalent (SESE)
Decision date
2007-10-18
Date received
2007-08-02
Regulation
876.1500
Classification name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JOHN J VOZELLA
Address
125 High St., Suite 7 Mansfield MA US 02048 02048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K092400ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5Endogastric Solutions, Inc.2009-11-06
K071553ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATORNdo Surgical, Inc.2007-09-18
K071651EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIESEndogastric Solutions, Inc.2007-09-14
K032820MODIFICATION TO ENDOSCOPIC PLICATION SYSTEMNdo Surgical, Inc.2003-10-23