Exufiber Ag+
FDA 510(k) K160379 · Molnlycke Health Care Us, LLC
510(k) numberK160379
Submission
- Device name
- Exufiber Ag+
- Applicant
- Molnlycke Health Care Us, LLC
Norcross, GA, US - Received
- February 10, 2016
- Decision date
- August 25, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
Other 510(k)s with product code FRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254041 | SkinSmart Antimicrobial HydroGelFRO · Traditional | Magic Science Supply, LLC | 09/11/2026SE |
| K261646 | Redermax® Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 08/14/2026SE |
| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
| K261023 | Microdacyn Wound Irrigation SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 06/24/2026SE |
| K251929 | SilverCeuticals® Antimicrobial Wound GelFRO · Traditional | Silverceuticals, Inc. | 06/24/2026SE |
| K261638 | Bonvadis®FRO · Special | Oneness Biotech Co., Ltd. | 06/17/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | Merit Medical Systems, Inc. | 05/13/2026SE |
| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
| K251999 | Promogran Prisma Collagen Matrix with ORC and SilverFRO · Traditional | Solventum Germany GmbH | 03/13/2026SE |
More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K232508 | Barrier EasyWarm Active Self-Warming BlanketDWJ · Special | 09/15/2023SE |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | 07/01/2021SE |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator…KGO · Traditional | 11/22/2020SE |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…KGO · Traditional | 04/10/2020SE |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim…KGO · Traditional | 03/13/2020SE |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO · Traditional | 05/24/2019SE |
| K161939 | Avance Abdominal Dressing KitOXJ · Traditional | 11/17/2016SE |
| K161935 | Avance Foam Dressing Kit - XLOMP · Traditional | 11/04/2016SE |
| K161948 | Avance Gauze Dressing KitsOMP · Traditional | 11/03/2016SE |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPadOMP · Traditional | 10/19/2016SE |
Questions and answers
When was Exufiber Ag+ cleared by the FDA?
Exufiber Ag+ (K160379) received a 510(k) decision of Substantially Equivalent on August 25, 2016, 197 days after the submission was received.
What is the product code of K160379?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.