G-SURG USA, INC.

FDA Device Registration & Listing · New York, NY, US · Registration 3032855354

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032855354
FEI Number
3032855354
Entity Name
G-SURG USA, INC.
City/State/Country
New York, NY, US
Establishment Address
120 Wall St Fl 20, New York, NY 10005, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
G-SURG USA, Inc. (Owner Number: 10091642)
Owner / Operator Contact Address
120 Wall Street, 20th Floor, New York, NY 10005, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K233240
PMA Number
N/A

All Registered Proprietary Names

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

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 2024-10-21

Official Correspondent

Julian Mair

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

G-SURG USA, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032855354. Last updated year: 2026. Please use registration number 3032855354 when referencing this establishment in official correspondence.
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