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Sign in to claim this brandKarl Storz GmbH & Co. (Kst)
US
Last updated May 23, 2026
What Karl Storz GmbH & Co. (Kst) makes
Karl Storz GmbH & Co. manufactures lithotriptor systems, including the Model 27080, which are designed for the non-invasive fragmentation of urinary stones using extracorporeal shockwave therapy.
The company’s lithotriptor systems fall under FDA Class II devices and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Karl Storz GmbH & Co. manufacture?
Karl Storz GmbH & Co. specializes in lithotriptor systems, such as the Model 27080. These devices are engineered for extracorporeal shockwave therapy, a non-invasive procedure used to break down urinary stones without surgery. The focus is on urological applications requiring precise fragmentation of kidney or bladder stones.
Where is Karl Storz GmbH & Co. based, and how does this affect its regulatory approach?
Karl Storz GmbH & Co. operates from the United States, which means its devices are subject to FDA regulations. Since lithotriptor systems like the Model 27080 fall under FDA Class II classification, they undergo premarket notification (510(k)) submissions to demonstrate substantial equivalence to a predicate device before entering the market.
Which regulatory registries or databases list Karl Storz’s lithotriptor systems?
Karl Storz’s lithotriptor systems, including the Model 27080, are documented in the FDA’s 510(k) registry. This pathway ensures transparency by recording the device’s compliance with FDA requirements, including design controls and performance data, before commercial distribution in the U.S.
How are Karl Storz’s lithotriptor systems classified by regulatory authorities?
The lithotriptor systems manufactured by Karl Storz GmbH & Co., such as the Model 27080, are classified as FDA Class II devices. This classification is based on their intended use for extracorporeal shockwave therapy, which carries moderate risk. Class II devices require special controls beyond general controls to ensure safety and effectiveness, typically demonstrated through 510(k) submissions.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (1989)
Page 1 of 40| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SilCut | 28171SBN | FDA UDI | Class I | Active |
| Vaporcut | 27043WG | FDA UDI | Class II | Active |
| SilCut | 28171KUN | FDA UDI | Class I | Active |
| Easygo! | 28163GTZ | FDA UDI | Class I | Active |
| Take-Apart | 26176HV | FDA UDI | Class II | Active |
| Take-Apart | 26176HT | FDA UDI | Class II | Active |
| Clickline | 33300 | FDA UDI | Class II | Active |
| Clickline | 30133 | FDA UDI | Class II | Active |
| D3-Link | TC302US | FDA UDI | Class II | Active |
| Hopkins | 1232CA | FDA UDI | Class II | Active |
| Clickline | 34210ES | FDA UDI | Class II | Active |
| Clickline | 30340AS | FDA UDI | Class II | Active |
| Silver Scope | 13925NKS | FDA UDI | Class II | Active |
| SilCut Square Punch | 28571SU | FDA UDI | Class I | Active |
| HOPKINS / SpineTIP | 28163BFA | FDA UDI | Class II | Active |
| Xenon Nova | 20131520 | FDA UDI | Class II | Active |
| Hopkins | 7220AA | EUDAMEDFDA UDI | Class II | Active |
| SilCut | 28171OAN | FDA UDI | Class I | Active |
| Clickline | 33543AL | FDA UDI | Class II | Active |
| Clickline | 30310ONG | FDA UDI | Class II | Active |
| Rhinoforce | 459012 | FDA UDI | Class I | Active |
| Clickline | 33610TH | FDA UDI | Class II | Active |
| Clickline | 25310ME | FDA UDI | Class II | Active |
| Rhinoforce | 651262V | FDA UDI | Class I | Active |
| C-Mac | 8401DXC | FDA UDI | Class I | Active |
| Hopkins | 49003AA | FDA UDI | Class II | Active |
| Clickline | 30310MGS | FDA UDI | Class II | Active |
| Hopkins | 28731CWA | FDA UDI | Class II | Active |
| Take-Apart | 26284AS | FDA UDI | Class II | Active |
| Hopkins | 27293AA | FDA UDI | Class II | Active |
| Clickline | 31110EH | FDA UDI | Class II | Active |
| ARTHROFORCE / Take-Apart | 28068BL | FDA UDI | Class II | Active |
| Robi | 38610CL | FDA UDI | Class II | Active |
| Vitom | 20916025AA | FDA UDI | Class I | Active |
| Robi | 38410MD | FDA UDI | Class II | Active |
| Hopkins | 27029AA | FDA UDI | Class II | Active |
| Clickline | 28164RS | FDA UDI | Class II | Active |
| Clickline | 30310R | FDA UDI | Class II | Active |
| Hopkins | 49003BA | FDA UDI | Class II | Active |
| C-Mac | 8401GXC | FDA UDI | Class I | Active |
| Clickline | 30240AS | FDA UDI | Class II | Active |
| Clickline | 30310UL | FDA UDI | Class II | Active |
| SilGrasp | 28572CG | FDA UDI | Class I | Active |
| Clickline | 30340VRS | FDA UDI | Class II | Active |
| MIP Minimal Invasive PCNL | 27830FL | FDA UDI | Class II | Active |
| Clickline | 28164LFA | FDA UDI | Class II | Active |
| Clickline | 33500 | FDA UDI | Class II | Active |
| Dci | 10331BD1 | FDA UDI | Class I | Active |
| Robi | 48510MT | FDA UDI | Class II | Active |
| Hopkins | 26003BEA | FDA UDI | Class II | Active |
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