Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026934906

FEI Number

3026934906

Entity Name

SURGVISION GMBH

City/State/Country

Muenchen Bavaria, DE

Establishment Address

Kistlerhofstr. 70 (building 79), Muenchen Bavaria 81379, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SurgVision GmbH (Owner Number: 10087568)

Owner / Operator Contact Address

Kistlerhofstr. 70 (building 79), Muenchen, DE-BY 81379, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222240

PMA Number

N/A

All Registered Proprietary Names

EXPLORER AIR II EXPLORER AIR Sterile Drape EXPLORER AIR Sterile Drape EXPLORER AIR II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2024-04-19
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2023-03-15
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2023-03-15

Official Correspondent

Adrian Taruttis

US Agent Details

Jonathan Watkins Business: ACIST Medical Systems, Inc. Email: jon.watkins@bracco.com Phone: (651) 8558002

Related Public Records

Same Entity

SurgVision GmbH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260108	Stryker Endoscopy	L12 LED Light Source with AIM	2026-02-12
K191144	Mauna Kea Technologies	Cellvizio 100 Series System with Confocal Miniprobes	2020-01-24
K243591	Optosurgical, LLC	OPTOVISION Endoscopic Light Source Unit	2025-02-19

Similar Registrations

Registration Number	Establishment Name	Location
3042243691	DIAGNOSTIC GREEN GMBH	Munich Bavaria, DE
3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
3015231789	Arthrex Manufacturing Inc.	Pendleton, SC, US
3009057691	LIFE SCIENCE LOGISTICS, LLC	Brownsburg, IN, US
3012127758	Siemens Healthcare Limited	Oakville Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026934906. Last updated year: 2026. Please use registration number 3026934906 when referencing this establishment in official correspondence.