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Sign in to claim this brandSutter Medizintechnik GmbH
US
Last updated May 26, 2026
What Sutter Medizintechnik GmbH makes
Sutter Medizintechnik GmbH manufactures reusable and single-use electrosurgical tools, including bipolar and monopolar handpieces, electrodes, and connection cables for surgical procedures. Their portfolio also includes instrument trays, foot-switches, and adaptors for electrosurgical systems, designed for both open-surgery and endoscopic applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) and UDI registries. The manufacturer is based in 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 Sutter Medizintechnik GmbH primarily manufacture?
Sutter Medizintechnik GmbH specializes in electrosurgical tools, producing both reusable and single-use devices. Their portfolio includes reusable electrosurgical handpieces and electrodes (bipolar and monopolar), connection cables, instrument trays, foot-switches, and adaptors. These devices are designed for surgical applications, covering open-surgery and endoscopic procedures, ensuring compatibility with electrosurgical systems.
Where is Sutter Medizintechnik GmbH based, and how does that affect its regulatory oversight?
Sutter Medizintechnik GmbH is based in the United States, which means its devices fall under FDA jurisdiction. The company’s products are classified as either Class I or Class II under FDA regulations, depending on their risk level and intended use. This classification determines the regulatory pathway for authorization, such as the 510(k) process for higher-risk devices like Class II electrosurgical tools.
Which regulatory registries list Sutter Medizintechnik GmbH’s devices, and why are these important?
Sutter Medizintechnik GmbH’s devices are recorded in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) process is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, while UDI ensures traceability and transparency in the supply chain. These registries help healthcare providers and regulators verify compliance and device history.
How are Sutter Medizintechnik GmbH’s devices classified under FDA regulations, and what does that mean for their use?
Sutter Medizintechnik GmbH’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory scrutiny and authorization process, ensuring appropriate oversight based on the device’s potential impact on patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sutter-med.de
- —
- —
- [email protected]
- Phone
- +49761515510
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 316625425
Catalogue (245)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sutter | 700983S | FDA UDI | Class II | Active |
| Sutter | 364428 | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 370150S | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 782387SLS | FDA UDI | Class II | Active |
| Sutter | 370130L | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 370154R | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 364472 | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 364442 | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 700969SGS | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 700990S | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 370150SG | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 700907S | FDA UDI | Class II | Active |
| Sutter | 370138A | FDA UDI | Class II | Active |
| Sutter | 780193SGS | FDA UDI | Class II | Active |
| Sutter | 780391SGS | FDA UDI | Class II | Active |
| Sutter | 780192SGS | FDA UDI | Class II | Active |
| Sutter | 780157SGS | FDA UDI | Class II | Active |
| Sutter | 370153A | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 370154A | FDA UDI | Class II | Active |
| Sutter | 700967SGS | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 780238SGS | FDA UDI | Class II | Active |
| Sutter | 783253SGS | FDA UDI | Class II | Active |
| Sutter | 370138K | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 370135K | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 364471 | EUDAMEDFDA UDI | Class II | Active |
| Sutter | AR-S9800-F1 | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 700920SGS | FDA UDI | Class II | Active |
| Sutter | 780190SGS | FDA UDI | Class II | Active |
| Sutter | 700958S | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 360100-01 | FDA UDI | Class II | Active |
| Sutter | 700918SGS | EUDAMEDFDA UDI | Class II | Active |
| Sutter | 782397SLS | FDA UDI | Class II | Active |
| Sutter | 701764 | EUDAMEDFDA UDI | Class I | Active |
| Sutter | 780381SGS | FDA UDI | Class II | Active |
| Sutter | 704495 | FDA UDI | Class II | Active |
| Sutter | 701778-01 | EUDAMEDFDA UDI | Class I | Active |
| Sutter Bipolar Forceps - Supergliss | K131012 | FDA 510(k) | Class II | Active |
| Sutter Bipolar Forceps-Calvian | K150959 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Sutter Swyng non-stick bipolar forceps, single-use | K193587 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| CURIS II RF Generator (REF 360100-05) | K251813 | FDA 510(k) | Class II | Active |
| Sutter Arrowtip Monopolar Electrodes | K192128 | FDA 510(k) | Class II | Active |
| Sutter RaVoR Bipolar Electrodes | K191732 | FDA 510(k) | Class II | Active |
| Sutter CURIS RF Generator | K171869 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | K233425 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Sutter Electrosurgical Cables | K073450 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sutter Medizintechnik Gmbh Emmendingen Baden-Wurttemberg · DE FEI 3004857377