Product code MGQ
- Device name
- Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171879 | HylaGuard Moisturizing Cream | Founders Science Group, LLC | 2017-10-16 |
| K083024 | HYLATOPIC EMOLLIENT FOAM | Collegium Pharmaceutical Incorporated | 2009-03-27 |
| K041342 | IMPRUV A.I. CREAM WOUND AND SKIN EMULSION | Stiefel Laboratories, Inc. | 2005-07-19 |
| K041268 | SILVERSITE OR CALGITROL | Adri | 2004-09-20 |
| K040019 | SILVERSEAL | Noble Fiber Technologies | 2004-07-23 |
| K040517 | TENDERWET ACTIVE | Medline Industries, Inc. | 2004-03-25 |
| K022587 | MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS | Medtrade Products , Ltd. | 2003-08-22 |
| K024367 | SINCLAIR WOUND AND SKIN EMULSION | Sinclair Pharmaceuticals, Ltd. | 2003-07-28 |
| K024054 | XYLOS XCELL ANTIMICROBIAL DRESSING | Xylos Corporation | 2003-03-07 |
| K022584 | CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING | Cardiotech Intl. | 2002-12-30 |
| K022995 | COLLATEK HYDROGEL | Biocore Medical Technologies, Inc. | 2002-12-02 |
| K013525 | CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) | Coloplast Corp. | 2002-10-04 |
| K020325 | L.A.M. IPM WOUND GEL | L.A.M. Pharmaceutical, Corp. | 2002-04-15 |
| K011994 | ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 | Acrymed, Inc. | 2001-11-08 |
| K010583 | AMBU GEL, HYDROGEL BURN DRESSING | Ambu, Inc. | 2001-05-25 |
| K002666 | DIAMOND ALOE VERA, STERILE | Medi-Tech Intl. Corp. | 2001-02-27 |
| K003396 | BURN JEL PLUS | Water-Jel Technologies, LLC | 2001-01-11 |
| K002077 | GLUCANPRO CREAM | Brennen Medical, Inc. | 2000-10-02 |
| K002078 | BETA GLUCAN GEL (MACROPRO GEL) | Brennen Medical, Inc. | 2000-10-02 |
| K002129 | FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN | Ferris Mfg. Corp. | 2000-08-25 |
| K000519 | GLUCANPRO | Brennen Medical, Inc. | 2000-05-01 |
| K000518 | MACROPRO GEL | Brennen Medical, Inc. | 2000-05-01 |
| K991755 | MEDLINE TENDER WET WOUND DRESSING | Medline Industries, Inc. | 2000-04-17 |
| K992074 | MPM REGENECARE WOUND GEL | Mpm Medical., Inc. | 1999-12-23 |
| K993119 | STERILE HYDROGEL | Dumex Medical Surgical Products, Ltd. | 1999-11-23 |
| K990178 | BURNFREE PAIN RELIEVING GEL, MODEL 4B | Nortrade Medical, Inc. | 1999-08-13 |
| K990180 | BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING | Nortrade Medical, Inc. | 1999-08-13 |
| K990179 | BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD | Nortrade Medical, Inc. | 1999-08-13 |
| K990440 | GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE | Gentell | 1999-08-12 |
| K991202 | MODIFICATION TO WOUN'DRES | Coloplast Corp. | 1999-06-04 |
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|---|---|---|---|
| 00368040753141 | Promiseb Topical Cream | Primus Pharmaceuticals, Inc. | 2026-05-01 |
| 00743537001033 | Water-Jel | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000791 | BurnFree | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000814 | BurnFree | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000838 | BurnFree | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000852 | Burn Stop | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000913 | Water-Jel | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000937 | Water-Jel | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000951 | Water-Jel | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000975 | Burn Stop | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000999 | Water-Jel | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537001019 | Water-Jel | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-11-01 |
| 00743537000777 | BurnFree | WATER-JEL TECHNOLOGIES, L.L.C. | 2024-10-31 |
| 10192253040142 | Kendall | Cardinal Health 200, LLC | 2024-04-15 |
| 10192253040135 | Kendall | Cardinal Health 200, LLC | 2024-04-15 |
| 10193489002928 | Medline | MEDLINE INDUSTRIES, INC. | 2024-01-01 |
| 10080196296576 | Medline | MEDLINE INDUSTRIES, INC. | 2023-06-13 |
| 10080196296606 | Medline | MEDLINE INDUSTRIES, INC. | 2023-06-13 |
| 10080196296583 | Medline | MEDLINE INDUSTRIES, INC. | 2023-06-13 |
| 10080196296545 | Medline | MEDLINE INDUSTRIES, INC. | 2023-06-13 |
| 10192253040128 | Kendall | Cardinal Health 200, LLC | 2023-01-19 |
| 00311701161168 | WOUN'DRES | Coloplast A/S | 2022-04-22 |
| 00311701161021 | WOUN'DRES | Coloplast A/S | 2022-04-22 |
| 10080196669837 | Medline | MEDLINE INDUSTRIES, INC. | 2021-08-21 |
| 10884521021938 | Kendall | Cardinal Health, Inc. | 2018-06-29 |
| 40884521021915 | Kendall | Cardinal Health, Inc. | 2018-06-27 |
| 10884521021921 | Kendall | Cardinal Health, Inc. | 2018-06-27 |
| 10884521007611 | Kendall | Cardinal Health, Inc. | 2018-06-27 |
| 10884521007604 | Kendall | Cardinal Health, Inc. | 2018-06-27 |
| 10884521007581 | Kendall | Cardinal Health, Inc. | 2018-06-27 |