Cleared Traditional

K233240 - GERDX-System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233240 · G-Surg GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
267d
Days
Class 2
Risk

K233240 is an FDA 510(k) clearance for the GERDX-System. Classified as Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (product code ODE), Class II - Special Controls.

Submitted by G-Surg GmbH (Seeon-Seebruck, DE). The FDA issued a Cleared decision on June 21, 2024 after a review of 267 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all G-Surg GmbH devices

Submission Details

510(k) Number K233240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date June 21, 2024
Days to Decision 267 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
137d slower than avg
Panel avg: 130d · This submission: 267d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Novineon CRO GmbH
Anna Pocsai

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.