DeviceClearance

XCelliStem Wound Powder— 510(k) K172593

Substantially Equivalent

Stemsys

FDA 510(k) clearance K172593 for XCelliStem Wound Powder, Substantially Equivalent on 2018-03-16. Applicant: Stemsys.

Clearance details

Applicant
Stemsys
Product code
Code KGN
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunrise, FL, US
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.