danumed Extension Set for Gastrostomy Button— 510(k) K260110
Substantially EquivalentDanumed Medizintechnik GmbH
FDA 510(k) clearance K260110 for danumed Extension Set for Gastrostomy Button, Substantially Equivalent on 2026-09-10. Applicant: Danumed Medizintechnik GmbH. Device class: 2.
Summary
The danumed Extension Set for Gastrostomy Button is filed under PIF, gastrointestinal tubes with enteral-specific connectors. The code's stated purpose is to facilitate enteral-specific connections.
Class II, 21 CFR 876.5980. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).
Danumed Medizintechnik filed from Regensburg, Germany. Review took 239 days (January 14 to September 10, 2026).
Clearance details
- Applicant
- Danumed Medizintechnik GmbH
- Product code
- Product code PIF
- 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 PIF
view allMore clearances from Danumed Medizintechnik GmbH
view allAdverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
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.