Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043746

FEI Number

3004595684

Entity Name

TROKAMED GMBH

City/State/Country

GEISINGEN Baden-Wurttemberg, DE

Establishment Address

KLEINE BREITE 17, GEISINGEN Baden-Wurttemberg 78187, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TROKAMED GMBH (Owner Number: 9003550)

Owner / Operator Contact Address

KLEINE BREITE 17, --, GEISINGEN, DE-BW 78187, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060232

PMA Number

N/A

All Registered Proprietary Names

MULTIPLE HYSTEROSCOPE ACCESSORIES Puncture Needle Palpation Probe MULTIPLE RING APPLICATORS Optical Biopsy Forceps, Urology Fan Retractor, Liver Elevator Frazer suction tube Puncture and Injection Cannula MULTIPLE MANUAL SU Trokamed Fascial Closure ("fsad") Trokamed Fascial Closure ( 11256-004 02-00092 11256-005 MULTIPLE MANUAL SU Trocar Sleeves and Accessories; Arthroscope and Accessories; Cystoscopes and Accessories; Verres Insufflation Cannula; Laparoscope and Accessories; Suction/Irrigation Systems, etc. LEF10097 ELECTROSURGICAL INSTR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-09-20
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2006-09-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-12-22
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2006-04-14
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2008-06-06
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2008-06-06
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2003-01-21
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2008-06-06
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-04-14
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2008-02-27
HXB	Probe	Orthopedic	Class 1	888.4540	2006-04-07
KBG	Trocar, Sinus	Ear, Nose, Throat	Class 1	874.4420	2006-09-14
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2015-04-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2006-09-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2006-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

TROKAMED GMBH

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
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
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

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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical 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 8043746. Last updated year: 2026. Please use registration number 8043746 when referencing this establishment in official correspondence.