510(k) K260532
K260532 is an FDA 510(k) premarket notification submitted by Geistlich Pharma AG for the device "Derma-Gide". The FDA issued a decision of Substantially Equivalent on March 19, 2026. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Geistlich Pharma AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2026
- Date Received
- February 17, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type