Product code NAE
- Device name
- Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4022
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K083721 | MODIFICATION TO ZENIEVA | River'S Edge Pharmaceuticals, LLC | 2009-01-08 |
| K082865 | MODIFICATION TO ZENIEVA | Gorbec Pharmaceutical Services, Inc. | 2008-10-23 |
| K073246 | ZENIEVA | Gorbec Pharmaceutical Services, Inc. | 2008-07-23 |
| K992094 | GILTECH PLUS HYDROGEL SKIN DRESSING | Giltech Plus, Inc. | 1999-09-17 |
| K991061 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | Dermaphylyx, Inc. | 1999-06-28 |
| K972646 | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | Ludlow Technical Products | 1997-08-21 |
| K971597 | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) | Coloplast Corp. | 1997-07-29 |
| K962352 | HYDROGEL SKIN DRESSING | North American Sterilization & Packaging Co. | 1996-08-02 |
| K952945 | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | Sherwood Medical Co. | 1995-08-23 |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | Bioderm, Inc. | 1995-06-21 |
| K950412 | CURAGEL HYDROGEL WOUND DRESSING | Kendall Healthcare Products Co. Div.Of Tyco Health | 1995-03-24 |
| K945832 | BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS | Brady Medical Products Co. | 1995-03-01 |
| K942748 | INTRASITE | Smith & Nephew United, Inc. | 1994-06-29 |
| K941019 | BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING | Brady Medical Products Co. | 1994-05-04 |
| K934601 | NDM HYDROGAUZE WOUND DRESSING | Ndm Acquisition Corp. | 1994-02-15 |
| K935705 | ALLEVYN ISLAND WOUND DRESSING | Smith & Nephew United, Inc. | 1994-02-15 |
| K935848 | BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING | Brady Medical Products Co. | 1994-02-15 |
| K932336 | NU-GEL ISLAND WOUND DRESSING | Johnson & Johnson Medical, Inc. | 1994-02-09 |
| K931618 | DUODERM HYDROCOLLOID GEL | Convatec, A Division of E.R. Squibb & Sons | 1993-12-10 |
| K926508 | INTRASITE GEL | Smith & Nephew United, Inc. | 1993-07-13 |
| K926202 | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI | Ndm Corp. | 1993-05-12 |
| K922666 | TRANSORB(TM) ULCER & WOUND DRESSING | Brady Medical Products Co. | 1992-11-23 |
| K915357 | PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH | Medtronic Vascular | 1992-05-28 |
| K915359 | PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH | Medtronic Vascular | 1992-05-28 |
| K920677 | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION | New Dimensions IN Medicine, Inc. | 1992-04-21 |
| K915182 | DEROYAL HYDROGEL DRESSING | Deroyal Industries, Inc. | 1992-04-21 |
| K914207 | CLEARSITE(R) STERILE WOUND CARE DRESSING | Ndm Acquisition Corp. | 1991-10-23 |
| K810902 | IP-758 BURN WOUND DRESSING | Exopack | 1981-09-11 |
| K802793 | LOMATUELL OINTMENT DRESSING | Secol Co. | 1980-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 01714196112452 | DermaRite Medical Wound Gel- Amorphous Hydrogel | Sion Brands LLC | 2026-06-01 |
| 10840330706350 | ProCure | Twin Med, LLC | 2026-04-22 |
| 10840330705810 | ProCure | Twin Med, LLC | 2026-04-22 |
| 10840330705803 | ProCure | Twin Med, LLC | 2026-04-22 |
| 10840330704943 | ProCure | Twin Med, LLC | 2026-04-22 |
| 10840330704936 | ProCure | Twin Med, LLC | 2026-04-22 |
| 10197344017508 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-10-23 |
| 20192253040156 | Kendall | Cardinal Health 200, LLC | 2025-09-26 |
| 15056860000058 | Gentell Hydrogel Sheet Dressing | Gentell, LLC | 2025-08-21 |
| 15056860000041 | Gentell Hydrogel Sheet Dressing | Gentell, LLC | 2025-08-21 |
| 15056860000034 | Gentell Hydrogel Sheet Dressing | Gentell, LLC | 2025-08-21 |
| 10197344110162 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-04 |
| M689HHWSK02050 | Wound Seal Kit | Safeguard US Operating, LLC | 2025-06-24 |
| 10192253040104 | Kendall | Cardinal Health 200, LLC | 2024-08-14 |
| 10192253040111 | Kendall | Cardinal Health 200, LLC | 2024-08-14 |
| 08809930750038 | YOUTH CELLACTION | Youth Bio Global Co., Ltd. | 2024-05-10 |
| 08809930750014 | YOUTH CELLACTION | Youth Bio Global Co., Ltd. | 2024-05-10 |
| 08809930750045 | YOUTH CELLACTION | Youth Bio Global Co., Ltd. | 2024-05-10 |
| 08809930750052 | YOUTH CELLACTION | Youth Bio Global Co., Ltd. | 2024-05-10 |
| 10193489149173 | Medline | MEDLINE INDUSTRIES, INC. | 2023-11-06 |
| 10612479193304 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2023-01-27 |
| 10612479193281 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2023-01-27 |
| 16958868749009 | Roosin | Roosin Medical Co., Ltd. | 2022-12-20 |
| 10303620002070 | Orasoothe Sockit Gel Syringe | SEPTODONT SAS SPECIALITES SEPTODONT | 2022-12-19 |
| 10080196669837 | Medline | MEDLINE INDUSTRIES, INC. | 2021-08-21 |
| 10080196669790 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-05-19 |
| 15051978010005 | NU-GEL® | SYSTAGENIX WOUND MANAGEMENT, LIMITED | 2019-09-24 |
| 15051978010012 | NU-GEL® | SYSTAGENIX WOUND MANAGEMENT, LIMITED | 2019-09-24 |
| 10884521057975 | Kendall | Cardinal Health, Inc. | 2018-06-30 |
| 10884521030893 | Kendall | Cardinal Health, Inc. | 2018-06-29 |