Gent-L-Kare(Tm) Sterile, Pressure Sore Manage Kit
FDA 510(k) K890107 · Premium Plastics, Inc.
510(k) numberK890107
Submission
- Device name
- Gent-L-Kare(Tm) Sterile, Pressure Sore Manage Kit
- Applicant
- Premium Plastics, Inc.
Elkhorn, WI, US - Received
- January 11, 1989
- Decision date
- October 24, 1989
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K953226 | Pulm O2 Suction Catheter TraysBSY · Traditional | 08/08/1995SE |
| K950851 | Gent-L-Kare Tracheostomy TraysLRQ · Traditional | 06/21/1995SE |
| K950850 | Gent-L-Kare Laceration TraysFRG · Traditional | 03/14/1995SN |
| K943740 | Roll-A-Way Sharps Disposal System (Red and Ivory)FMI · Traditional | 12/14/1994SE |
| K893135 | Gent-L-Kare Ster Suct Cath Tray W/14 Fr/Ster WaterJOL · Traditional | 06/22/1989SE |
| K850285 | Gent-L-Kare Sterile Urethral Catheterization TrayKOD · Traditional | 02/28/1985SE |
| K800440 | Sterile Sponge BowlsFNY · Traditional | 04/29/1980SE |
| K771448 | Sterile Suture Removal KitKDD · Traditional | 09/06/1977SE |
Questions and answers
When was Gent-L-Kare(Tm) Sterile, Pressure Sore Manage Kit cleared by the FDA?
Gent-L-Kare(Tm) Sterile, Pressure Sore Manage Kit (K890107) received a 510(k) decision of Unknown on October 24, 1989, 286 days after the submission was received.
What is the product code of K890107?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.