Medline Tender Wet Wound Dressing
FDA 510(k) K991755 · Medline Industries, Inc.
510(k) numberK991755
Submission
- Device name
- Medline Tender Wet Wound Dressing
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- May 24, 1999
- Decision date
- April 17, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | 07/29/2026SE |
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | 06/22/2026SE |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant…BZE · Traditional | 03/25/2026SE |
| K251687 | Konig Bell Circumcision ClampHFX · Traditional | 02/25/2026SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | 11/20/2025SE |
| K250345 | Medline Bag DecanterLHI · Traditional | 10/24/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | 07/02/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | 04/11/2025SE |
| K242844 | Medline Level 4 Surgical Gown with Breathable SleevesFYA · Traditional | 02/26/2025SE |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle…GEI · Traditional | 12/19/2024SE |
Questions and answers
When was Medline Tender Wet Wound Dressing cleared by the FDA?
Medline Tender Wet Wound Dressing (K991755) received a 510(k) decision of Substantially Equivalent on April 17, 2000, 329 days after the submission was received.
What is the product code of K991755?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.