SurgiAid® Collagen Wound Dressing
FDA 510(k) K223126 · Maxigen Biotech, Inc.
510(k) numberK223126
Submission
- Device name
- SurgiAid® Collagen Wound Dressing
- Applicant
- Maxigen Biotech, Inc.
Taoyuan City, TW - Received
- October 3, 2022
- Decision date
- October 11, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | 09/03/2026SE |
| K242100 | SurgiAid Collagen Wound Dressing (HA)KGN · Traditional | 10/16/2025SE |
| K230529 | HealiAid Dental Collagen Wound DressingOLR · Traditional | 11/22/2023SE |
| K100927 | SurgiaidKGN · Traditional | 02/02/2011SE |
Questions and answers
When was SurgiAid® Collagen Wound Dressing cleared by the FDA?
SurgiAid® Collagen Wound Dressing (K223126) received a 510(k) decision of Substantially Equivalent on October 11, 2023, 373 days after the submission was received.
What is the product code of K223126?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.