Product Code: NAC FDA class 1 21 CFR 878.4018

Dressing, Wound, Hydrophilic

General, Plastic Surgery

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).

510(k)s
4
FEI Numbers
500
Registration Numbers
500
Unique Applicants
4
Years Active
17

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number Device Name
K082208 DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
K925841 HYDRASORB JOYCE SPONGE
K914779 ALGINATE FIBER
K914575 SORBSAN TOPICAL WOUND DRESSING (MODIFIED)

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.