Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680809

FEI Number

3002995060

Entity Name

MEDI-GLOBE GMBH

City/State/Country

Achenmuhle, Germany Bavaria, DE

Establishment Address

Medi-Globe Strasse 1-5, Achenmuhle, Germany Bavaria 83101, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MEDI-GLOBE GMBH (Owner Number: 9011628)

Owner / Operator Contact Address

MEDI-GLOBE-STRASSE, 1-5, --, ACHENMUHLE, DE-BY D-83101, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251658

PMA Number

N/A

All Registered Proprietary Names

SonoTip Pro and Pro Flex EBUS-TBNA Needle System ClickTip Injectra SonoTip II Clear View Pro Control Vizeon Clear View SonoTip II 25 gauge EUS needle Vizeon Pro Control Orbit-Snare RotaSnare Endoflux Biliary & Pancreatic Stent Sets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2014-05-22
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-11-12
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2007-11-12
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2009-05-21
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2007-11-12
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2026-04-29

Official Correspondent

Stephan Schneider

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

MEDI-GLOBE GMBH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004129994	MEDI-GLOBE SRO	HRANICE Olomouc, CZ
3011146996	MEDI-GLOBE GMBH	VELEN North Rhine-Westphalia, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K902734	Olympus Corp.	PR CANNULAS	1990-08-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680809. Last updated year: 2026. Please use registration number 9680809 when referencing this establishment in official correspondence.