510(k) clearance
danumed Extension Set for Gastrostomy Button
- 510(k) number
- K260110
- Applicant
- Danumed Medizintechnik GmbH
- Decision date
- Sep 10, 2026
- Date received
- Jan 14, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PIF
- Device type
- Gastrointestinal Tubes With Enteral Specific Connectors
- Device class
- Class II
- Regulation
- 21 CFR 876.5980
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Regensburg, DE