Reclosable Wound Cover
FDA 510(k) K954621 · Hollister, Inc.
510(k) numberK954621
Submission
- Device name
- Reclosable Wound Cover
- Applicant
- Hollister, Inc.
Libertyville, IL, US - Received
- October 5, 1995
- Decision date
- October 23, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | 05/18/2026SE |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…EZD · Traditional | 10/03/2025SE |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…EZD · Traditional | 05/03/2024SE |
| K220667 | Sleeved ICEZD · Traditional | 12/08/2022SE |
| K213575 | Female IC (Not Finalized)EZD · Traditional | 09/13/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | 01/27/2022SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | 12/13/2019SE |
| K191633 | Infyna ChicGBM · Special | 07/19/2019SE |
| K183253 | ValPro 2 Plus, VaPro 2 Plus PocketGBM · Special | 12/18/2018SE |
| K180824 | VaPro 2 Intermittent CatheterGBM · Special | 06/22/2018SE |
Questions and answers
When was Reclosable Wound Cover cleared by the FDA?
Reclosable Wound Cover (K954621) received a 510(k) decision of Substantially Equivalent for Some Indications on October 23, 1995, 18 days after the submission was received.
What is the product code of K954621?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.