Silversite or Calgitrol
FDA 510(k) K041268 · Adri
510(k) numberK041268
Submission
- Device name
- Silversite or Calgitrol
- Applicant
- Adri
Park Forest, IL, US - Received
- May 12, 2004
- Decision date
- September 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K022995 | Collatek HydrogelMGQ · Traditional | Biocore Medical Technologies, Inc. | 12/02/2002SE |
More from Biocore Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011618 | Calgitrol AG Silver Alginate Wound DressingFRO · Traditional | 11/15/2002SE |
| K000054 | Foam Calcium Alginate Topical Wound Dressing with CollagenKGN · Traditional | 03/13/2000SE |
| K963656 | Foam Calcium Aliginate Topical Wound DressingKMF · Traditional | 11/12/1996SE |
| K940404 | Alginate Fiber Topical Wound DressingKMF · Traditional | 05/04/1994SN |
| K870383 | Alginate Wool FiberKHR · Traditional | 04/30/1987SE |
Questions and answers
When was Silversite or Calgitrol cleared by the FDA?
Silversite or Calgitrol (K041268) received a 510(k) decision of Substantially Equivalent on September 20, 2004, 131 days after the submission was received.
What is the product code of K041268?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.