510(k) clearance
danumed StomaMeter
- 510(k) number
- K262038
- Applicant
- Danumed Medizintechnik GmbH
- Decision date
- Sep 30, 2026
- Date received
- Jun 17, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KNT
- Device type
- Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II
- Regulation
- 21 CFR 876.5980
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Regensburg, DE