Dermassist(Tm) Xeroform Petrolatum Dressing
FDA 510(k) K941005 · Wilshire Medical Products
510(k) numberK941005
Submission
- Device name
- Dermassist(Tm) Xeroform Petrolatum Dressing
- Applicant
- Wilshire Medical Products
Dallas, TX, US - Received
- March 1, 1994
- Decision date
- April 14, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
|---|---|---|
| K946031 | Dermassist(Tm) Hydrogel Saturateed Non Woven DressingMGQ · Traditional | 02/27/1995SE |
| K946030 | Dermassist(Tm) Hydrogel Saturated Gauze DressingMGQ · Traditional | 02/27/1995SE |
| K944333 | Hydroderm Gel Wound DressingMGQ · Traditional | 11/10/1994SN |
| K941216 | Hydroderm Extra Thin Intelligent Hydrocollioid DressingKMF · Traditional | 05/20/1994SN |
| K941149 | Dermaassist Hydrocolloid DressingFRO · Traditional | 05/20/1994SN |
| K940076 | Dermassist Wet Dressing, WaterFRO · Traditional | 03/03/1994SE |
| K940044 | Dermassist Wet Dressing, SalineFRO · Traditional | 03/03/1994SE |
| K936234 | Dermassist Oil Emulsion Non-Adhering Wound DressingFRO · Traditional | 03/03/1994SE |
| K936230 | Dermassist Petrolatum Gauze,UspFRO · Traditional | 03/03/1994SE |
| K935796 | Hydroderm Breathable Transparent DressingMGP · Traditional | 02/02/1994SE |
Questions and answers
When was Dermassist(Tm) Xeroform Petrolatum Dressing cleared by the FDA?
Dermassist(Tm) Xeroform Petrolatum Dressing (K941005) received a 510(k) decision of Substantially Equivalent for Some Indications on April 14, 1994, 44 days after the submission was received.
What is the product code of K941005?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.