danumed StomaMeter— 510(k) K262038
Substantially EquivalentDanumed Medizintechnik GmbH
FDA 510(k) clearance K262038 for danumed StomaMeter, Substantially Equivalent on 2026-09-30. Applicant: Danumed Medizintechnik GmbH. Device class: 2.
Summary
The danumed StomaMeter is filed under KNT, gastrointestinal tubes and accessories. The name suggests a measuring tool related to stomas, but the record doesn't describe what it measures or how it's used, so that reading stays a guess.
Class II, 21 CFR 876.5980. It went through the Gastroenterology and Urology panel as a Traditional 510(k).
Danumed Medizintechnik GmbH filed from Regensburg, Germany. Review took 105 days (June 17 to September 30, 2026).
Clearance details
- Applicant
- Danumed Medizintechnik GmbH
- Product code
- Product code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Regensburg, DE
Recent devices under product code KNT
view allMore clearances from Danumed Medizintechnik GmbH
view allAdverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.