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510(k) K260532

Derma-Gide by Geistlich Pharma AG — Product Code KGN

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

Other clearances by Geistlich Pharma AG

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  • K251062 — Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; G (August 14, 2025)
  • K251556 — Device 300423 Granules (July 17, 2025)
  • K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (July 11, 2025)
  • K251613 — SwissGraft X (June 26, 2025)
  • K250833 — SwissMembrane X; SwissMembrane X Socket (April 15, 2025)
  • K242510 — Geistlich Bio-Flow® (March 7, 2025)
  • K241802 — Device 300397 Putty (November 8, 2024)
  • K240661 — Geistlich Bio-Oss® (July 12, 2024)

Other clearances for product code KGN

  • K260218 — LacertaMatrix (February 19, 2026)
  • K253140 — CollOvine™ Wound Powder (February 10, 2026)
  • K251323 — Device 104 Particulate (January 22, 2026)
  • K252673 — LacertaMatrix (December 22, 2025)
  • K253339 — Theracor (December 22, 2025)
  • K250864 — MatriDerm pluS+ Bi-Layer (December 19, 2025)
  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K250397 — Helios Dermal Scaffold (August 15, 2025)
  • K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (July 16, 2025)