Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009051888

FEI Number

3009051888

Entity Name

Applied Medical Distribution Center

City/State/Country

Irvine, CA, US

Establishment Address

9401 Toledo Way, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Medical 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

K060673

PMA Number

N/A

All Registered Proprietary Names

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device GelPOINT Path Transanal Access Platform Alexis® Lighted Wound Protector-Retractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2018-04-16
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-05-19
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	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
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-01-27
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-04-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-08
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-19
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-06-11
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2026-04-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-01-25
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2014-01-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2012-02-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-12-11
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2020-12-18
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2013-11-21
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-12-19
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-19
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2007-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-11-26
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2007-12-19
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2017-12-11
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-11-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-19
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-04-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2000-04-18
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2013-11-21
FTF	Illuminator, Non-Remote	General, Plastic Surgery	Class 2	878.4580	2026-04-20
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2026-04-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-12-19
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2007-12-19
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-19
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2002-12-11
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-12-19
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	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	2008-12-16
FHF	System, Evacuator, Fluid	Gastroenterology, Urology	Class 2	876.4370	2007-12-19
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-11-28
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-19
MOK	Vaginoscope And Accessories	Obstetrics/Gynecology	Class 2	884.1630	2022-11-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-08-22
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	2018-11-19
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
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2007-12-19

Official Correspondent

Leilani Domingo

US Agent Details

No US Agent registered (Local establishment).

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
3009763019	Applied Medical Europe	Amersfoort Utrecht, NL
2027111	APPLIED MEDICAL RESOURCES CORP.	RSM, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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

Similar Registrations

Registration Number	Establishment Name	Location
3016804805	CLEARCAM	Austin, TX, US
3011936016	Sony Olympus Medical Solutions Inc.	Hachioji-shi Tokyo, JP
3015335150	VERNACARE LTD.	Chorley Lancashire, GB
1221072	VASCULAR TECHNOLOGY INCORPORATED	NASHUA, NH, US
3021744308	Lazurite Inc.	Cleveland, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009051888. Last updated year: 2026. Please use registration number 3009051888 when referencing this establishment in official correspondence.