510(k) K262038
K262038 is an FDA 510(k) premarket notification submitted by Danumed Medizintechnik GmbH for the device "danumed StomaMeter". The FDA issued a decision of Substantially Equivalent on Sep 30, 2026. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Danumed Medizintechnik GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2026
- Date Received
- Jun 17, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)