Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010871

FEI Number

6166

Entity Name

SMI MEDICAL INSTRUMENTS GMBH & CO.KG

City/State/Country

NEUHAUSEN OB ECK Baden-Wurttemberg, DE

Establishment Address

Robert Bosch Strasse 36, NEUHAUSEN OB ECK Baden-Wurttemberg D-78579, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SMI MEDICAL INSTRUMENTS GMBH & CO KG (Owner Number: 8010871)

Owner / Operator Contact Address

ROBERT-BOSCH-STRASSE 36, --, NEUHAUSEN OB ECK, DE-NOTA D-78579, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

3795-01BP

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	2013-01-14
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1988-02-08
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1988-02-08
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1988-02-08
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2004-05-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-07-23
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2014-05-14
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-05-12
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2014-11-26
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2022-11-14
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1988-02-08
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2013-01-10
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1988-02-08
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1988-02-08
HTX	Rongeur	Orthopedic	Class 1	888.4540	2004-05-12
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-01-14
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1988-02-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-11-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1988-02-08

Official Correspondent

FLORIAN STRITZEL

US Agent Details

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

Related Public Records

Same Entity

SMI MEDICAL INSTRUMENTS GMBH & CO KG

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-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-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010871. Last updated year: 2026. Please use registration number 8010871 when referencing this establishment in official correspondence.