DeviceClearance

KIMGUARD ONE STEP STERILIZATION WRAP— 510(k) K141712

Substantially Equivalent

Halyard Health

FDA 510(k) clearance K141712 for KIMGUARD ONE STEP STERILIZATION WRAP, Substantially Equivalent on 2014-12-18. Applicant: Halyard Health.

Clearance details

Applicant
Halyard Health
Product code
Code FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FRG

product code FRG
Other
3
Total
3

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.