Cleared Traditional

K072125 - ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT

K072125 is an FDA 510(k) clearance for ENDOSCOPIC PLICATION SYSTEM, manufactured by Ndo Surgical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ODE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K072125 · Ndo Surgical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
77d
Days
Class 2
Risk

K072125 is an FDA 510(k) clearance for the ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT. Classified as Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (product code ODE), Class II - Special Controls.

Submitted by Ndo Surgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on October 18, 2007 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ndo Surgical, Inc. devices

FDA 510(k) Submission Details - K072125

510(k) Number K072125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2007
Decision Date October 18, 2007
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 131d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODE Device Classification - Class 2, Special Controls

Product Code ODE Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ODE Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)

All 16
Devices cleared under the same product code (ODE) and FDA review panel - the closest regulatory comparables to K072125.
SRS ENDOSCOPIC STAPLING SYSTEM
K132151 · Medigus , Ltd. · Mar 2014
SRS ENDOSCOPIC STAPLING SYSTEM
K120299 · Medigus , Ltd. · May 2012
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
K092400 · Endogastric Solutions, Inc. · Nov 2009
ENDOSCOPIC PLICATION SYSTEM
K071553 · Ndo Surgical, Inc. · Sep 2007
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
K071651 · Endogastric Solutions, Inc. · Sep 2007
BARD ENDOCINCH SUTURING SYSTEM # 000452
K003956 · C.R. Bard, Inc. · Jan 2001