Last synced on 11 April 2025 at 11:05 pm

Absorbable Synthetic Wound Dressing

Page Type
Product Code
Definition
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Physical State
Commonly a solid sheet
Technical Method
Physical barrier to cover the wound and provide a moist wound environment.
Target Area
Topical wounds
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QSZ is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.

Absorbable Synthetic Wound Dressing

Page Type
Product Code
Definition
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Physical State
Commonly a solid sheet
Technical Method
Physical barrier to cover the wound and provide a moist wound environment.
Target Area
Topical wounds
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QSZ is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.