Dressing, Wound, Hydrophilic
The Hydrophilic Wound Dressing is a wound care product designed with moisture-retaining hydrophilic properties that help maintain a moist wound healing environment, promoting tissue regeneration and reducing pain associated with wound care. It is used for the management of partial and full-thickness wounds. Classified as FDA Class 1, it is subject to general controls under regulation 878.4018 (General and Plastic Surgery specialty).
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Basic Information
- Product Code
- NAC
- Device Class
- FDA class 1
- Regulation Number
- 878.4018
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K082208 | DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER | Dec 01, 2008 | Substantially Equivalent | Scivolutions, Inc. |
| K925841 | HYDRASORB JOYCE SPONGE | May 12, 1993 | Substantially Equivalent | Avitar, Inc. |
| K914779 | ALGINATE FIBER | Dec 04, 1991 | Substantially Equivalent | Adri/Technam |
| K914575 | SORBSAN TOPICAL WOUND DRESSING (MODIFIED) | Dec 04, 1991 | Substantially Equivalent | Dow B. Hickam, Inc. |
FEI Numbers
This FDA classification entry is associated with 500 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 500 registration numbers. Click on an entry to view related FDA registrations.