Cleared Traditional

ENDOSCOPIC PLICATION SYSTEM (K023234) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023234 · Ndo Surgical, Inc. · General & Plastic Surgery device
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Apr 2003
Decision
202d
Days
Class 2
Risk

K023234 is an FDA 510(k) clearance for the ENDOSCOPIC PLICATION SYSTEM. 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 April 17, 2003 after a review of 202 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ndo Surgical, Inc. devices

Submission Details

510(k) Number K023234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2002
Decision Date April 17, 2003
Days to Decision 202 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 115d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 General & Plastic Surgery devices follow this clearance model.

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

All 19
Devices cleared under the same product code (ODE) and FDA review panel - the closest regulatory comparables to K023234.
GERDX-System
K233240 · G-Surg GmbH · Jun 2024
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K240879 · Endogastric Solutions, Inc. · Apr 2024
BARD ENDOCINCH SUTURING SYSTEM # 000452
K003956 · C.R. Bard, Inc. · Jan 2001
BARD ENDOSCOPIC SUTURING SYSTEM
K994290 · C.R. Bard, Inc. · Mar 2000