Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1057358

FEI Number

1000208608

Entity Name

RG Medical USA

City/State/Country

Mount Juliet, TN, US

Establishment Address

630A Pleasant Grove Rd., Mount Juliet, TN 37122, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

RG Medical USA (Owner Number: 9007726)

Owner / Operator Contact Address

630 Pleasant Grove Rd., Mount Juliet, TN 37122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K933772

PMA Number

N/A

All Registered Proprietary Names

RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical RG Medical

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	2009-03-25
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2009-03-25
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-03-25
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2009-03-25
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2009-03-25
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2009-03-25
EYN	Tray, Irrigation, Sterile	Gastroenterology, Urology	Class 2	876.5980	2009-03-25
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2009-03-25
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2011-02-09
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2011-02-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-06-27
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2012-05-25
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-05-25
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2006-11-15
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2011-02-09
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2018-06-28
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2011-02-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-02-09
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2010-12-29
DWG	Electrosurgical Device	General, Plastic Surgery	Class 2	878.4400	2011-02-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-02-09
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-01-11
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2018-01-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-02-09
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2009-03-25
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2011-02-09
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2011-02-09
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2011-02-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-02-09
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2011-02-09
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-01-11
DWG	Electrosurgical Device	General, Plastic Surgery	Class 2	878.4400	2011-02-09
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2011-02-09
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2011-02-09
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2011-02-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2011-02-09

Official Correspondent

Winfried Reich

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RG Medical USA

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
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-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1057358. Last updated year: 2026. Please use registration number 1057358 when referencing this establishment in official correspondence.