Hydroderm Gel Wound Dressing
FDA 510(k) K944333 · Wilshire Medical Products
510(k) numberK944333
Submission
- Device name
- Hydroderm Gel Wound Dressing
- Applicant
- Wilshire Medical Products
Dallas, TX, US - Received
- September 6, 1994
- Decision date
- November 10, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
Other 510(k)s with product code MGQ
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| K171879 | HylaGuard Moisturizing CreamMGQ · Traditional | Founders Science Group, LLC | 10/16/2017SE |
| K083024 | Hylatopic Emollient FoamMGQ · Traditional | Collegium Pharmaceutical Incorporated | 03/27/2009SE |
| K041342 | Impruv A.I. Cream Wound and Skin EmulsionMGQ · Traditional | Stiefel Laboratories, Inc. | 07/19/2005SE |
| K041268 | Silversite or CalgitrolMGQ · Traditional | Adri | 09/20/2004SE |
| K040019 | SilversealMGQ · Traditional | Noble Fiber Technologies | 07/23/2004SE |
| K040517 | Tenderwet ActiveMGQ · Traditional | Medline Industries, Inc. | 03/25/2004SE |
| K022587 | Medtrade Product's Antiseptic Barrier Hydrogel DressingsMGQ · Traditional | Medtrade Products , Ltd. | 08/22/2003SE |
| K024367 | Sinclair Wound and Skin EmulsionMGQ · Traditional | Sinclair Pharmaceuticals, Ltd. | 07/28/2003SE |
| K024054 | Xylos Xcell Antimicrobial DressingMGQ · Traditional | Xylos Corporation | 03/07/2003SE |
| K022584 | Cardiotech Antibotic Hydrogel Wound DressingMGQ · Traditional | Cardiotech Intl. | 12/30/2002SE |
More from Cardiotech Intl.
| 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 |
| K941216 | Hydroderm Extra Thin Intelligent Hydrocollioid DressingKMF · Traditional | 05/20/1994SN |
| K941149 | Dermaassist Hydrocolloid DressingFRO · Traditional | 05/20/1994SN |
| K941005 | Dermassist(Tm) Xeroform Petrolatum DressingFRO · Traditional | 04/14/1994SN |
| 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 Hydroderm Gel Wound Dressing cleared by the FDA?
Hydroderm Gel Wound Dressing (K944333) received a 510(k) decision of Substantially Equivalent for Some Indications on November 10, 1994, 65 days after the submission was received.
What is the product code of K944333?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.