Fibrcol Plus Collagen Wound Dressing with Alginate
FDA 510(k) K982597 · Johnson & Johnson Medical, Inc.
510(k) numberK982597
Submission
- Device name
- Fibrcol Plus Collagen Wound Dressing with Alginate
- Applicant
- Johnson & Johnson Medical, Inc.
Arlington, TX, US - Received
- July 24, 1998
- Decision date
- August 20, 1998
- 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
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| K260596 | Collagen Wound PowderKGN · Traditional | Ventris Medical | 07/02/2026SE |
| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
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| K253204 | CatalyzeKGN · Traditional | BioTissue Holdings, Inc. | 06/05/2026SE |
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| 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 |
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| K033523 | Collagen-Orc Antimicrobial MatrixFRO · Traditional | 10/21/2004SE |
| K022483 | Actisorb Silver 220 Antimicrobial Binding DressingFRO · Traditional | 02/03/2003SE |
| K014129 | Promogran Matrix Wound DressingKGN · Traditional | 02/14/2002SE |
| K001690 | Protectiv Safety Blood Collection NeedleFMI · Traditional | 07/31/2000SE |
| K982641 | Advanced Nibp ModuleDXN · Traditional | 03/29/1999SE |
| K983362 | Nu-Gel * Wound DressingMGQ · Traditional | 12/16/1998SE |
| K974080 | Critikon Soft Blood Pressure CuffDXQ · Traditional | 05/18/1998SE |
| K980493 | I.V. Catheter SystemFOZ · Traditional | 04/28/1998SE |
| K972498 | Observer * Central StationDSI · Traditional | 02/17/1998SE |
| K973699 | Ultralon Powder Free Latex Surgical GloveKGO · Traditional | 12/16/1997SE |
Questions and answers
When was Fibrcol Plus Collagen Wound Dressing with Alginate cleared by the FDA?
Fibrcol Plus Collagen Wound Dressing with Alginate (K982597) received a 510(k) decision of Substantially Equivalent on August 20, 1998, 27 days after the submission was received.
What is the product code of K982597?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.