DORNIER MEDTECH AMERICA, INC.

FDA Device Registration & Listing · KENNESAW, GA, US · Registration 1037955

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
1037955
FEI Number
1037955
Entity Name
DORNIER MEDTECH AMERICA, INC.
City/State/Country
KENNESAW, GA, US
Establishment Address
1155 ROBERTS BLVD., KENNESAW, GA 30144, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Dornier MedTech America, Inc. (Owner Number: 1037955)
Owner / Operator Contact Address
1155 ROBERTS BLVD., Suite 100, Kennesaw, GA 30144, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K251923
PMA Number
N/A

All Registered Proprietary Names

Medilas H RFID Laser Fibers Medilas H Solvo 35 Laser Medilas H Ball Tip Laser Fiber Medilas H RFID Laser Fiber Thulio Medilas H Slim Laser Fiber DORNIER MEDILAS H Dornier MedTech America, Inc. MAGELLAN Access Sheath

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2025-08-07
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-02-12
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-10-17
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-11-21
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-06-07
FGO Dislodger, Stone, Flexible Gastroenterology, Urology Class 2 876.4680 2018-10-29
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-05-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-04-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-12-06
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-06-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-08-22
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2020-06-16
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-05-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-07-09
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Gastroenterology, Urology Class 2 876.5990 2023-03-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-12-06
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 1992-10-26
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2024-01-03
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2019-01-22
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-04-24
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-06-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-06-27
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-06-27
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2020-01-27
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2020-01-27
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2021-03-08
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2020-01-27
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2025-02-21
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2022-11-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-06-12

Official Correspondent

John Hoffer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dornier MedTech America, Inc.
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
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
K240075 FUJIFILM Healthcare Americas Corporation FUJIFILM Endoscope Model EB-710XT 2024-02-07
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2020 AURIS HEALTH INC 2
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0006-2013 US Endoscopy Group Inc 2
Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

Similar Registrations

Registration Number Establishment Name Location
3004065885 Creation Technologies Everett, WA, US
3005099803 BOSTON SCIENTIFIC CORPORATION Marlborough, MA, US
8010047 OLYMPUS MEDICAL SYSTEMS CORP. HACHIOJI-SHI Tokyo, JP
3015970743 CENTERPOINT SYSTEMS LLC West Valley City, UT, US
3008729892 MEDIPLAST ISRAEL LTD Yavne Tel Aviv, IL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037955. Last updated year: 2026. Please use registration number 1037955 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.