Karl Storz SE & Co. KG
⚠️ High Risk
FEI: 3002808268 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3002808268
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Dr.-Karl-Storz-Str. 11, , Tuttlingen, Baden-Wurttemberg, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2024 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/6/2018 | 77EOQBRONCHOSCOPE (FLEXIBLE OR RIGID) | Division of Southeast Imports (DSEI) | |
| 8/29/2017 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/6/2017 | 85HIHHYSTEROSCOPE (AND ACCESSORIES) | Division of Southeast Imports (DSEI) | |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/15/2013 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/4/2013 | 78GCILARYNGOSCOPE | New Orleans District Office (NOL-DO) | |
| 10/11/2012 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 508NO 510(K) | New England District Office (NWE-DO) |
| 4/4/2011 | 78FECOBTURATOR, FOR ENDOSCOPE | Detroit District Office (DET-DO) | |
| 8/11/2010 | 85HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 8/11/2010 | 78FAJCYSTOSCOPE, DIAGNOSTIC | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 10/8/2009 | 78FAJCYSTOSCOPE, DIAGNOSTIC | 341REGISTERED | Detroit District Office (DET-DO) |
| 9/8/2005 | 78NTPCOLONOSCOPE, AUTOMATIC, SEMI-AUTOMATIC, SYSTEMS AND ACCESSORIES | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Karl Storz SE & Co. KG's FDA import refusal history?
Karl Storz SE & Co. KG (FEI: 3002808268) has 21 FDA import refusal record(s) in our database, spanning from 9/8/2005 to 10/24/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Karl Storz SE & Co. KG's FEI number is 3002808268.
What types of violations has Karl Storz SE & Co. KG received?
Karl Storz SE & Co. KG has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Karl Storz SE & Co. KG come from?
All FDA import refusal data for Karl Storz SE & Co. KG is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.