Product code NAC
- Device name
- Dressing, Wound, Hydrophilic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4018
- 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 |
|---|---|---|---|
| K082208 | DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER | Scivolutions, Inc. | 2008-12-01 |
| K925841 | HYDRASORB JOYCE SPONGE | Avitar, Inc. | 1993-05-12 |
| K914575 | SORBSAN TOPICAL WOUND DRESSING (MODIFIED) | Dow B. Hickam, Inc. | 1991-12-04 |
| K914779 | ALGINATE FIBER | Adri/Technam | 1991-12-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06940610127725 | Vliwasorb | Huizhou Foryou Medical Devices Co., Ltd. | 2026-08-14 |
| 06940610127787 | Vliwasorb | Huizhou Foryou Medical Devices Co., Ltd. | 2026-08-14 |
| 06940610127848 | Vliwasorb | Huizhou Foryou Medical Devices Co., Ltd. | 2026-08-14 |
| 06940610127879 | Vliwasorb | Huizhou Foryou Medical Devices Co., Ltd. | 2026-08-14 |
| 06940610127909 | Vliwasorb | Huizhou Foryou Medical Devices Co., Ltd. | 2026-08-14 |
| 06940610127930 | Vliwasorb | Huizhou Foryou Medical Devices Co., Ltd. | 2026-08-14 |
| 06937935316927 | Sacral Silicone Superabsorbent Dressing | Shanghai Iso Medical Products Co., Ltd. | 2026-08-03 |
| 06979191882280 | Nanacare | WAL-MART STORES, INC. | 2026-07-31 |
| 06979191881979 | OKTAPE | HTT Technologies, Inc. | 2026-07-31 |
| 06979191881962 | OKTAPE | HTT Technologies, Inc. | 2026-07-31 |
| 06979191881955 | OKTAPE | HTT Technologies, Inc. | 2026-07-31 |
| 06974692681561 | GUANGYI | Jiangsu Guangyi Medical Dressing Co.,LTD. | 2026-07-22 |
| 01714196637702 | HydraLock SA with Border | Sion Brands LLC | 2026-07-16 |
| 01714196635500 | HydraLock SA with Border | Sion Brands LLC | 2026-07-16 |
| 01714196634404 | HydraLock SA with Border | Sion Brands LLC | 2026-07-16 |
| 00850087488433 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00850087488440 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00850087488518 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00819143021373 | Healqu | Healqu LLC | 2023-11-09 |
| 00819143021052 | Healqu | Healqu LLC | 2023-11-08 |
| 00819143021069 | Healqu | Healqu LLC | 2023-11-08 |
| 04042809557305 | CutimedĀ® SiltecĀ® | BSN medical GmbH | 2022-12-08 |
| 20894689001595 | Restore | HOLLISTER INCORPORATED | 2022-12-01 |
| 20894689001571 | Restore | HOLLISTER INCORPORATED | 2022-12-01 |
| 20894689001557 | Restore | HOLLISTER INCORPORATED | 2022-12-01 |
| 20894689001533 | Restore | HOLLISTER INCORPORATED | 2022-12-01 |
| 10610075029560 | CalciCare | HOLLISTER INCORPORATED | 2022-12-01 |
| 10610075029553 | CalciCare | HOLLISTER INCORPORATED | 2022-12-01 |
| 10610075029546 | CalciCare | HOLLISTER INCORPORATED | 2022-12-01 |
| 10610075029539 | CalciCare | HOLLISTER INCORPORATED | 2022-12-01 |