Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010697

FEI Number

3004053982

Entity Name

GEISTER MEDIZINTECHNIK GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

FOEHRENSTR. 2, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GEISTER MEDIZINTECHN (Owner Number: 8010697)

Owner / Operator Contact Address

FOEHRENSTR. 2, --, TUTTLINGEN, DE-NOTA D-78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GEISTER® K-Rex rongeurs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2002-05-07
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2025-06-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-02-05
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2018-08-30
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2016-02-17
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2014-04-16
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2002-05-07
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2001-04-16
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2013-10-30
NJZ	Extractor, Vein	General, Plastic Surgery	Class 1	878.4800	2021-09-21
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2002-05-07
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2015-01-12
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2002-04-15
HTX	Rongeur	Orthopedic	Class 1	888.4540	2002-05-07
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-06-23
DWI	Saw, Electrically Powered	General, Plastic Surgery	Class 1	878.4820	2008-02-01
MGZ	Valvulotome	Cardiovascular	Class 2	870.4885	2007-11-15
HXB	Probe	Orthopedic	Class 1	888.4540	1997-05-27
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	2009-04-23
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	1997-05-27
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1997-05-27
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2007-11-15
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2002-01-08
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2002-05-07
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1996-04-09
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1983-09-27
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2018-08-21
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-08-26
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2003-12-10
DRC	Trocar	Cardiovascular	Class 2	870.1390	2015-01-12
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2003-05-23
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	1990-11-07
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1986-05-16
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2012-11-08
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-11-15
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1997-05-27
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-05-27
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-04-25
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2019-12-05
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-27

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

GEISTER MEDIZINTECHN

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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-0031-05	N/A	1	Hem-o-lok Endo5 Ligation Applier

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010697. Last updated year: 2026. Please use registration number 8010697 when referencing this establishment in official correspondence.