K-number	K242100
Device name	SurgiAid Collagen Wound Dressing (HA)
Applicant	Maxigen Biotech, Inc.
Product code	KGN
Device class	Class U
Decision date	Oct 16, 2025
Decision	Substantially Equivalent
Regulation	—

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

SurgiAid® Collagen Wound Dressing is a medical device intended for wound care applications. The device is classified as unclassified with product code KGN and has received FDA clearance to market based on substantial equivalence to predicate devices.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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SurgiAid Collagen Wound Dressing (HA)

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