Geistlich Derma-Gide
FDA 510(k) K182838 · Geistlich Pharma AG
510(k) numberK182838
Submission
- Device name
- Geistlich Derma-Gide
- Applicant
- Geistlich Pharma AG
Wolhusen, CH - Received
- October 9, 2018
- Decision date
- November 8, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code KGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260652 | ColActive PlusKGN · Traditional | Covalon Technologies, Ltd. | 09/09/2026SE |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | Berkeley Advanced Biomaterials | 08/27/2026SE |
| K260596 | Collagen Wound PowderKGN · Traditional | Ventris Medical | 07/02/2026SE |
| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
| K253521 | ECMT-100 WMDKGN · Traditional | Ecm Therapeutics, Inc. | 06/18/2026SE |
| K253204 | CatalyzeKGN · Traditional | BioTissue Holdings, Inc. | 06/05/2026SE |
| K254034 | Roosin Collagen PowderKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K253974 | Roosin Collagen DressingKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K261224 | MatriDermKGN · Special | Medskin Solutions Dr. Suwelack AG | 05/14/2026SE |
| K260532 | Derma-GideKGN · Special | Geistlich Pharma AG | 03/19/2026SE |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K260364 | Device 300419 StripMQV · Traditional | 06/02/2026SE |
| K260532 | Derma-GideKGN · Special | 03/19/2026SE |
| K251323 | Device 104 ParticulateKGN · Traditional | 01/22/2026SE |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®NPL · Traditional | 11/25/2025SE |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…NPL · Traditional | 08/14/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | 07/17/2025SE |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPM · Special | 07/11/2025SE |
| K251613 | SwissGraft XNPM · Special | 06/26/2025SE |
| K250833 | SwissMembrane X; SwissMembrane X SocketNPL · Special | 04/15/2025SE |
| K242510 | Geistlich Bio-Flow®NPM · Traditional | 03/07/2025SE |
Questions and answers
When was Geistlich Derma-Gide cleared by the FDA?
Geistlich Derma-Gide (K182838) received a 510(k) decision of Substantially Equivalent on November 8, 2018, 30 days after the submission was received.
What is the product code of K182838?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.