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 connects a low-profile feeding button in the stomach wall to a feeding line. It's filed under PIF, gastrointestinal tubes with enteral-specific connectors. That code exists because of ENFit, the connector standard designed to keep feeding sets from being hooked up to IV lines.
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
- 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 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.