Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K251323

Device 104 Particulate

510(k) number
K251323
Device name
Device 104 Particulate
Applicant
Geistlich Pharma AG CH
Product code
KGN — Wound Dressing With Animal-Derived Material(S)
Decision date
2026-01-22
Date received
2025-04-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Unknown
510(k) Summary (official FDA PDF): K251323.pdf
Official FDA record: K251323
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.