Device 104 Particulate— 510(k) K251323

Substantially Equivalent

Geistlich Pharma AG

FDA 510(k) clearance K251323 for Device 104 Particulate, Substantially Equivalent on 2026-01-22. Applicant: Geistlich Pharma AG.

Clearance details

Applicant
Geistlich Pharma AG
Product code
Code KGN
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wolhusen, CH
Download summary PDFView on FDA.gov ↗

Adverse events under product code KGN

product code KGN
Other
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.