Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009763019

FEI Number

3009763019

Entity Name

Applied Medical Europe

City/State/Country

Amersfoort Utrecht, NL

Establishment Address

Wiekenweg 21, Amersfoort Utrecht 3815 KL, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

APPLIED MEDICAL RESOURCES (Owner Number: 2027111)

Owner / Operator Contact Address

22872 AVENIDA EMPRESA, --, Rancho Santa Margarita, CA 92688, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K062907

PMA Number

N/A

All Registered Proprietary Names

GelPOINT Path Transanal Access Platform

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2007-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-08-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-02-16
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-05-12
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2013-11-21
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-11-19
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2019-09-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-12-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-11-26
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2000-04-18
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-12-16
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-19
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2012-02-07
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2020-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-04-16
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2013-11-21
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2002-12-11
DSS	Clip, Vascular	Cardiovascular	Class 2	870.3250	2007-12-19
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2014-01-27
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-12-19
FHF	System, Evacuator, Fluid	Gastroenterology, Urology	Class 2	876.4370	2007-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-07-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-04-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-05-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-05-12
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2017-12-11
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-11-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-08-22
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-19
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2007-12-19
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2007-12-19

Official Correspondent

Leilani Domingo

US Agent Details

Leilani Domingo Business: Applied Medical Resources Email: ldomingo@appliedmedical.com Phone: (949) 7138317

Related Public Records

Same Entity

APPLIED MEDICAL RESOURCES

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2027111	APPLIED MEDICAL RESOURCES CORP.	RSM, CA, US
3009051888	Applied Medical Distribution Center	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0012-2023	Hobbs Medical, Inc.	2	Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009763019. Last updated year: 2026. Please use registration number 3009763019 when referencing this establishment in official correspondence.