Data / Medical devices / Switzerland / Storz Medical AG
Storz Medical AG: FDA-registered device maker in TAEGERWILEN Thurgau, Switzerland, 13 510(k) clearances and 2 PMA approvals
Storz Medical AG is registered with the FDA (registration 9613347) in TAEGERWILEN Thurgau, Switzerland. It lists 9 device types. The FDA files 13 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613347
- FEI number
- 3002808188
- Address
- Lohstampfestrasse 8, TAEGERWILEN Thurgau, Switzerland, 8274
- Owner or operator
- STORZ MEDICAL AG (9028780)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- CHATTANOOGA Intelect F-SW USA, CHATTANOOGA Mobile 2 RPW USA, D-ACTOR 100, D-ACTOR 200, D-ACTOR 50, DUOLITH SD1 R-SW, DUOLITH SD1 T-TOP, DUOLITH SD1 T-Top and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | PZL | 2 | Manufacturer | accessdata.fda.gov |
| Generator, Shock-Wave, For Pain Relief | NBN | 3 | Manufacturer | accessdata.fda.gov |
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
| Vibrator, Therapeutic | IRO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 3, 2021 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | IPF | Substantially Equivalent | Storz Medical AG | accessdata.fda.gov |
| March 30, 2021 | K201001 | Modulith SLX-F2 | LNS | Substantially Equivalent | Karl Storz Endoscopy America | accessdata.fda.gov |
| February 21, 2021 | K202112 | Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece | PZL | Substantially Equivalent | Storz Medical AG | accessdata.fda.gov |
| December 29, 2020 | K200965 | XR-MX/1000 | JAA | Substantially Equivalent | Karl Storz Endoscopy America, Inc. | accessdata.fda.gov |
| April 13, 2018 | K173692 | D-Actor 200 Vibration Massage System | ISA | Substantially Equivalent | Storz Medical AG | accessdata.fda.gov |
| June 12, 2012 | K120769 | MODULTH SLK | LNS | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| March 18, 2010 | K093603 | STORM-BASE 2.0 | LLZ | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| December 26, 2007 | K072788 | STORZ MODULITH LITHOTRIPTER SLX-F2-F180 | LNS | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 30, 2007 | K070579 | STORZ SLX-F2 STORM TOUCH | LNS | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 26, 2004 | K040476 | STORZ MODULITH, MODEL SLX-F2 | LNS | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| August 16, 2002 | K011700 | MODULITH SLK LITHOTRIPTER | LNS | Substantially Equivalent | Karl Storz Endoscopy | accessdata.fda.gov |
| October 16, 2001 | K012482 | STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION | LNS | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| February 13, 2001 | K010340 | MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI | LNS | Substantially Equivalent | Karl Storz Lithotripsy-America, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 8, 2016 | P080028 | STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY | NBN | 1 | February 5, 2020 | accessdata.fda.gov |
| February 17, 1995 | P920051 | STORZ MODULITH (TM) LITHOTRIPTER | LNS | 7 | October 31, 1997 | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Lithotriptor, Extracorporeal Shock-Wave, Urological
- All makers of Generator, Shock-Wave, For Pain Relief
- All makers of Vibrator, Therapeutic
- All makers of Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
- All makers of System, Image Processing, Radiological
Updated May 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.