Derma-Gide— 510(k) K260532
Substantially EquivalentGeistlich Pharma AG
FDA 510(k) clearance K260532 for Derma-Gide, Substantially Equivalent on 2026-03-19. Applicant: Geistlich Pharma AG. Device class: Unclassified.
Summary
Geistlich Pharma's Derma-Gide is filed under KGN, wound dressings with animal-derived material. The record doesn't list sizes or describe the dressing beyond its name and that code name.
The device class is listed as U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Special 510(k).
Geistlich Pharma filed from Wolhusen, Switzerland. Review took 30 calendar days (February 17 to March 19, 2026).
Clearance details
- Applicant
- Geistlich Pharma AG
- Product code
- Product code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wolhusen, CH
Recent devices under product code KGN
view allMore clearances from Geistlich Pharma AG
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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.