Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1418479

FEI Number

1418479

Entity Name

RICHARD WOLF MEDICAL INSTRUMENTS CORP.

City/State/Country

VERNON HILLS, IL, US

Establishment Address

353 CORPORATE WOODS PKWY., VERNON HILLS, IL 60061, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RICHARD WOLF GMBH (Owner Number: 8010049)

Owner / Operator Contact Address

PFORZHEIMER STR. 32, --, KNITTLINGEN, DE-NOTA 75438, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2016-09-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-09-20
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-09-20
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2016-09-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2009-06-18
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-05-06
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2019-05-06
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2019-05-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-20
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2016-09-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-09-20
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2010-03-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-11-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-05-11
GCM	Endoscope, Rigid	Gastroenterology, Urology	Class 2	876.1500	2009-05-11
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2010-03-30
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2009-11-18
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2009-11-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-20
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-09-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-09-20
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2016-09-19
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2010-04-08
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2010-04-08
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	1978-03-31
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	1998-02-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-09-19
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2016-08-23
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2016-08-23
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2016-08-23
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2016-08-23
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2016-09-20
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2016-09-20
HDP	Elevator, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2011-07-29
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2011-07-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RICHARD WOLF GMBH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611102	RICHARD WOLF GMBH	KNITTLINGEN Baden-Wurttemberg, DE

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-0037-2015	Richard Wolf Medical Instruments Corp.	3	The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1418479. Last updated year: 2026. Please use registration number 1418479 when referencing this establishment in official correspondence.