KARL STORZ VIDEO ENDOSCOPY ESTONIA OUE

FDA Device Registration & Listing · Laagri Harjumaa, EE · Registration 3004644065

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
3004644065
FEI Number
3004644065
Entity Name
KARL STORZ VIDEO ENDOSCOPY ESTONIA OUE
City/State/Country
Laagri Harjumaa, EE
Establishment Address
Parnu mnt 556b, Laagri Harjumaa 76401, EE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
KARL STORZ SE & CO KG (Owner Number: 8010119)
Owner / Operator Contact Address
Dr.-Karl-Storz-Strasse 34,, TUTTLINGEN, DE-BW 78532, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RHINO-PHARYNGO-LARYNGO FIBERSCOPE Xenon 100 CMOS Video-Rhino-Laryngoscope System Endoscope Accessories SSU Flexible Video-Uretero-Renoscope KARL STORZ Endoscopic Accessories for Urology Cleaning Brushes and kits KARL STORZ VIDEO GASTROSCOPES Video Gastroscopes Flexible Intubation Video Endoscope – Sterile (FIVE-S) Video Flexible ENT Endoscope System Light source system, diagnostic endoscopic

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2007-11-20
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2009-03-24
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2019-04-09
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2007-12-03
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-01-20
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2026-06-17
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2011-01-18
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2007-03-20
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2007-03-20
FWF Camera, Television, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2007-03-20
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2022-01-04
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2007-10-18
OAY Light Source System, Diagnostic Endoscopic Unknown Class 3 N/A 2010-09-16

Official Correspondent

No official correspondent registered.

US Agent Details

Anja Fair Business: KARL STORZ ENDOSCOPY-AMERICA, INC. Email: anja.fair@karlstorz.com Phone: (346) 8168200

Related Public Records

Same Entity

KARL STORZ SE & CO KG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3032429484 KARL STORZ Endovision, Inc. Franklin, MA, US
3006546082 KARL STORZ SE & CO. KG TUTTLINGEN Baden-Wurttemberg, DE
3014342096 KARL STORZ SE & CO KG TUTTLINGEN Baden-Wurttemberg, DE
2020550 KARL STORZ ENDOSCOPY-AMERICA, INC. Auburn, MA, US
9610617 KARL STORZ SE & CO. KG TUTTLINGEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K923489 Cox Medical Ent., Inc. COX DISPOSABLE RETRIEVAL DEVICES 1992-09-23
K232314 FUJIFILM Healthcare Americas Corporation Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) 2023-09-01
K811059 Pentax Precision Instrument Corp. PENTAX BRONCHOFIBERSCOPE #FB-15A 1981-05-27
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0015-2023 Hobbs Medical, Inc. 2
Hobbs Medical Polypectomy Snare Catalog Number: 4563
Z-0016-2023 Hobbs Medical, Inc. 2
Hobbs Medical Polypectomy Snare Catalog Number: 4564
Z-0026-2023 Hobbs Medical, Inc. 2
Hobbs Helical Retrieval Basket Catalog Number: 4806
Z-0027-2023 Hobbs Medical, Inc. 2
Hobbs Helical Retrieval Basket Catalog Number: 4808
Z-0028-2023 Hobbs Medical, Inc. 2
Hobbs Helical Retrieval Basket Catalog Number: 4814

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3010202439 Karl Storz Endoscopy-America, Inc. El Segundo, CA, US
3014342096 KARL STORZ SE & CO KG TUTTLINGEN Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004644065. Last updated year: 2026. Please use registration number 3004644065 when referencing this establishment in official correspondence.
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