DeviceClearance

Dukal SMS Sterilization Wrap— 510(k) K233262

Substantially Equivalent

Dukal, LLC

FDA 510(k) clearance K233262 for Dukal SMS Sterilization Wrap, Substantially Equivalent on 2024-03-22. Applicant: Dukal, LLC.

Clearance details

Applicant
Dukal, LLC
Product code
Code FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ronkonkoma, NY, 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.