Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033508651

FEI Number

3033508651

Entity Name

G-SURG GMBH

City/State/Country

Seeon-Seebruck Bavaria, DE

Establishment Address

Weinbergstrasse 28, Seeon-Seebruck Bavaria 83370, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

G-SURG GmbH (Owner Number: 10091470)

Owner / Operator Contact Address

Weinbergstrasse 28, Seeon-Seebruck, DE-BY 83370, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233240

PMA Number

N/A

All Registered Proprietary Names

GERDX - Guide Wire GERDX - Suture System GERDX - Applicator GERDX - Tissue Retractor GERDX - Implant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	Gastroenterology, Urology	Class 2	876.1500	2024-10-07

Official Correspondent

Julian Mair

US Agent Details

Julian Mair Business: G-SURG USA, Inc. Email: j.mair@g-surg.com Phone: (212) 5849708

Related Public Records

Same Entity

G-SURG GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033508651. Last updated year: 2026. Please use registration number 3033508651 when referencing this establishment in official correspondence.