GUENTER STOFFEL MEDIZINTECHNIK GMBH

FDA Device Registration & Listing · WURMLINGEN Baden-Wurttemberg, DE · Registration 8010370

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8010370
FEI Number
4417
Entity Name
GUENTER STOFFEL MEDIZINTECHNIK GMBH
City/State/Country
WURMLINGEN Baden-Wurttemberg, DE
Establishment Address
KANTSTR. 37, WURMLINGEN Baden-Wurttemberg D-78573, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
GUENTER STOFFEL MEDIZINTECHNIK GMBH (Owner Number: 8010370)
Owner / Operator Contact Address
KANTSTR. 37, --, WURMLINGEN, DE-BW D-78573, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INSTO BIOPSY FORCEPS Anastomosis Blade Holder Disposable Bioptome INSTO MICRO INSTRUMENTS INSTO NEEDLE HOLDER

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2004-11-10
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2009-07-29
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2001-09-05
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 2004-11-10
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2025-04-28
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2004-11-10
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2009-07-29
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-06-27
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2007-12-01
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-04-28
HXD Clamp General, Plastic Surgery Class 1 878.4800 2009-07-29
FFN Clamp, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2014-06-27
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2006-07-13
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2004-11-10
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2004-11-10
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2001-09-05
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2014-06-27
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2004-11-10
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 1978-03-11
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-04-28
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2009-10-18

Official Correspondent

DIETER STOFFEL

US Agent Details

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

Related Public Records

Same Entity

GUENTER STOFFEL MEDIZINTECHNIK 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
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28
K923489 Cox Medical Ent., Inc. COX DISPOSABLE RETRIEVAL DEVICES 1992-09-23
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-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011 Depuy Orthopaedics, Inc. 1
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010370. Last updated year: 2026. Please use registration number 8010370 when referencing this establishment in official correspondence.
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